Arthrex® AR-9597-20Recalls & reported problems
Arthrex, Inc. · ANGLED REAMER SLEEVE, 20° · Class 1
Quick summary
This Arthrex angled reamer sleeve, a hand-held instrument used to prepare bone during shoulder replacement, has 114 adverse event reports on file. Most describe the sleeve sticking or jamming so the reamer shaft spins or will not move, and some describe parts cold-welded together. The reports include no deaths and no injuries, and the number of reports fell from 21 to 4 over the last 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 114
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 00888867343450), received between Aug 11, 2023 and Apr 9, 2026 — classified as 114 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (92 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking92
- Mechanical Jam12
- Material Twisted/Bent6
- Defective Device5
- Naturally Worn3
- Break2
- Device Damaged by Another Device2
- Damaged Thread1
Patient problems
- No Clinical Signs, Symptoms or Conditions98
- Insufficient Information18
Recent adverse event reports
The 25 most recent of 114 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2026Physical Resistance/Sticking
ON 19-MAR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9597-20 ANGLED REAMER SLEEVE BECAME JAMMED CAUSING THE ENTIRE REAMER SHAFT TO SPIN. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24834651 ↗MalfunctionMar 12, 2026Physical Resistance/Sticking
ON 19-FEB-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9676T AUGMENTED DRIVE SHAFT LOCKING REAMER GOT BOUND UP AND WOULD ONLY MOVE AS ONE PIECE AS OPPOSED TO THE INNER SHEATH ROTATING FREELY WITHIN THE OUTER SHEATH OF AN AR-9597-20 ANGLED REAMER SLEEVE. THE REVERSE TOTAL SHOULDER ARTHROPLASTY WAS COMPLETED SUCCESSFULLY BY USING ANOTHER TRAY, WITH NO PATIENT AFFECTED. ADDITIONAL INFORMATION WAS RECEIVED ON 25-FEB-2026. THE REP ADVISED THAT AN ARTHREX REPRESENTATIVE WAS PRESENT. THE PATIENT HAD STANDARD BONE QUALITY, AND THE AUGMENTED MGS REAMER WAS USED TO PREPARE THE BONE SOCKET FOR INSERTION OF THE IMPLANT. THERE WERE NO ADDITIONAL SCREWS OR PLATES THAT CONTAINED A PRODUCT ALLEGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24586215 ↗MalfunctionMar 12, 2026Physical Resistance/Sticking
ON (B)(6), A FACILITY REPRESENTATIVE REPORTED VIA SEMS-(B)(4) THAT AN AR-9676T AUGMENTED DRIVE SHAFT LOCKING REAMER GOT BOUND UP, AND WOULD ONLY MOVE AS ONE PIECE AS OPPOSED TO THE INNER SHEATH ROTATING FREELY WITHIN THE OUTER SHEATH OF AN AR-9597-20 ANGLED REAMER SLEEVE. THE REVERSE TOTAL SHOULDER ARTHROPLASTY WAS COMPLETED SUCCESSFULLY BY USING ANOTHER TRAY, WITH NO PATIENT AFFECTED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6). THE REP ADVISED THAT AN ARTHREX REPRESENTATIVE WAS PRESENT. THE PATIENT HAD STANDARD BONE QUALITY, AND THE AUGMENTED MGS REAMER WAS USED TO PREPARE THE BONE SOCKET FOR INSERTION OF THE IMPLANT. THERE WERE NO ADDITIONAL SCREWS OR PLATES THAT CONTAINED A PRODUCT ALLEGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24580668 ↗MalfunctionNov 4, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ADDITIONAL INFORMATION WAS REPORTED BY THE SALES REP ON (B)(6) 2026, THAT THIS OCCURRED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY WITH AUGMENTED BASEPLATE. A GLENOID WAS BEING REAMED AND THE PATIENT'S BONE QUALITY WAS FAIR AND FIRM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465535 ↗MalfunctionAug 20, 2025Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking
ON 07/22/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9597-20 ANGLED REAMER SLEEVE, AND AN AR-9676 ANGLED REAMER COLD WELDED TOGETHER. THIS OCCURRED DURING A CASE, THEY WERE ABLE TO PULL THEM APART, BUT THEY ARE NOW BENT AND WILL NOT FIT TOGETHER PROPERLY THERE WERE NO ADVERSE PATIENT EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22850289 ↗MalfunctionAug 5, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 07/16/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9597-20 ANGLED REAMER SLEEVE WAS COLD WELDED WITH INSIDE OF THE REAMER. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED 7/21/25 THAT THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY. AFTER THE 20 DEGREE MGS AUGMENT REAMER MALFUNCTIONED, THE 25 DEGREE PRIMARY AUGMENT REAMER WAS USED TO COMPLETE REAMING. ADDITIONAL INFORMATION WAS PROVIDED ON 7/24/25 THAT THE SLEEVE WAS STUCK TO THE DRIVE SHAFT. PART NUMBER AND SN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22717432 ↗MalfunctionAug 5, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 07/16/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9597-20 ANGLED REAMER SLEEVE WAS COLD-WELDED WITH AN AR-9676 ANGLED REAMER AND NO LONGER WORKS. THIS WAS DISCOVERED AFTER THE CASE. THERE WAS NO ADVERSE EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22713362 ↗MalfunctionApr 22, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ADDITIONAL INFORMATION WAS RECEIVED ON 04/21/2025: THE ANGLED REAMER DRIVE SHAFT BECAME BOUND WITH THE AR-9597-20 ANGLED REAMER SLEEVE 20°. AT THIS TIME, THE PART AND LOT NUMBER OF THE ANGLED REAMER DRIVE SHAFT IS UNKNOWN. THE CASE WAS COMPLETED BY OPENING A BACKUP ARTHREX AUGMENTED MGS INSTRUMENT SET. NO CASE DELAY OR ADDED ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED ON OR AFTER THE SURGERY. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 04/24/2025: THE PART AND LOT NUMBER OF THE ANGLED REAMER DRIVE SHAFT ARE UNKNOWN, BUT IT HAS FUNCTIONED WELL WITH ANOTHER ANGLED REAMER SLEEVE AND HAS BEEN RETURNED TO CIRCULATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21885568 ↗MalfunctionMar 13, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 02/26/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9597-20 REAMER SLEEVE AND AR-9676 REAMER SHAFT ARE WELDED TOGETHER. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21596869 ↗MalfunctionFeb 24, 2025Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9597-20 ANGLED REAMER SLEEVE AND AN AR-9676 ANGLED REAMER BOUND UP INTERNALLY AND SUBSEQUENTLY BECAME COLD WELDED. THIS OCCURRED DURING A PROCEDURE ON (B)(6) 2025 THE INSTRUMENTS EXHIBITED AN UNEXPECTED MECHANICAL FAILURE, WHEREIN THEY BOUND UP INTERNALLY AND SUBSEQUENTLY BECAME COLD-WELDED, RENDERING THEM NON-FUNCTIONAL. THE MALFUNCTION WAS IDENTIFIED INTRAOPERATIVELY, REQUIRING THE SURGICAL TEAM TO OPEN A SECONDARY TRAY TO COMPLETE THE PROCEDURE. WHILE NO PATIENT HARM WAS SUSTAINED, THE ATTENDING SURGEON EXPRESSED SIGNIFICANT DISSATISFACTION WITH THE EVENT. THE FAILURE OF THE INSTRUMENTS LED TO OPERATIONAL INEFFICIENCIES AND PROCEDURAL DELAYS, IMPACTING THE OVERALL WORKFLOW OF THE CASE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21448264 ↗MalfunctionFeb 24, 2025Material Twisted/Bent; Material Twisted/Bent
ON 02/07/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9597-20 ANGLED REAMER SLEEVE BENT. THIS OCCURRED DURING A CASE, WITH NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21447618 ↗MalfunctionFeb 21, 2025Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9676 ANGLED REAMER DRIVE SHAFT AND AN AR-9597-20 ANGLED REAMER SLEEVE FUSED TOGETHER. THIS WAS DISCOVERED DURING AN RTSA PROCEDURE AND WAS COMPLETED WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21432174 ↗MalfunctionFeb 19, 2025Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9676 ANGLED REAMER WOULDN'T SLIDE SMOOTHLY WITH THE AR-9597-20 ANGLED REAMER SLEEVE. THIS OCCURRED DURING A CASE, WHILE REAMING THE GLENOID THE ANGLED REAMER DRIVER SHAFT DIDN'T SLIDE SMOOTHLY WITH THE ANGLED REAMER SLEEVE ON POWER. THIS JERKED THE SURGEON'S WRIST CAUSING REAMING TO BE DIFFICULT. THESE INSTRUMENTS WERE PUT TO THE SIDE AND A BACK UP TRAY WAS OPENED. THE CASE CARRIED ON AND WAS COMPLETED SUCCESSFULLY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21413008 ↗MalfunctionFeb 19, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 02/04/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9676 ANGLED REAMER WAS DIFFICULT TO GET INTO THE AR-9597-20 ANGLED REAMER SLEEVE. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER PROCEDURE WHEN THE SURGEON BEGAN TO REAM THE DEVICES EVENTUALLY STOPPED MOVING. THE REPRESENTATIVE HAD TO BEAT THE DRIVER SHAFT TO GET IT OUT OF THE REAMER SLEEVE.
Patient problems: Insufficient Information
MAUDE report 21410513 ↗MalfunctionJan 29, 2025Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking
ON 01/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06748654 THAT AN AR-9676 ANGLED REAMER WAS STUCK INSIDE OF THE AR-9597-20 ANGLED REAMER SLEEVE. THIS OCCURRED DURING A CASE WITH NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21265664 ↗MalfunctionJan 22, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 12/27/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(6) THAT AN AR-9676 ANGLED REAMER, DRIVE SHAFT AND AN AR-9597-20 ANGLED REAMER SLEEVE, 20° WERE SEIZED TOGETHER AND STUCK. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025: THIS WAS DISCOVERED DURING AN RTSA PROCEDURE. THE CASE WAS COMPLETED USING AN OPENED BACKUP TRAY. THERE WAS A 3-MINUTE CASE DELAY WHILE THE BACKUP TRAY WAS OPENED AND THE ANGLED REAMER ASSEMBLED. ADDITIONAL INFORMATION WAS RECEIVED ON 01/16/2025: THIS WAS DISCOVERED DURING AN RTSA PROCEDURE ON (B)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21210676 ↗MalfunctionJan 14, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 12/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06738566 THAT AN AR-9676 ANGLED REAMER, DRIVE SHAFT AND AN AR-9597-20 ANGLED REAMER SLEEVE, 20° FUSED TOGETHER. THERE WAS NO CASE OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21149165 ↗MalfunctionJan 9, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 12/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9676 ANGLED REAMER DRIVE SHAFT WAS WELDED TOGETHER WITH THE AR-9597-20 ANGLED REAMER SLEEVE, 20° AND CAUSED THE SURGEON'S WRIST TO SUDDENLY TWIST AND MAKES THE REAMING DIFFICULT. A SECOND AR-9597-20 ANGLED REAMER SLEEVE, 20°, WAS USED, AND THE INCIDENT OCCURRED A SECOND TIME. THE CASE WAS CARRIED OUT SUCCESSFULLY WITH A DIFFERENT REAMER SLEEVE AND DRIVESHAFT. THIS WAS DISCOVERED DURING AN RTSA PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 12/17/2024: THERE WAS NO CASE DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21118788 ↗MalfunctionJan 9, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 9/8/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06025851 THAT AN AR-9597-20 ANGLED REAMER SLEEVE HAD AN ISSUE DURING A RTSA PROCEDURE ON (B)(6) 2023. THE ANGLED REAMER WAS GETTING HUNG UP WITH THE SHAFT INSERTED. THERE WAS NO HARM TO THE PATIENT, AND THE CASE WAS ONLY DELAYED 3 MINUTES. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 9/26/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THE INSTRUMENT WAS DEEMED UNSATISFACTORY/UNUSABLE DURING THE CASE. WHEN THE DEVICE GOT HUNG UP DURING THE CASE, ANOTHER INSTRUMENT TRAY WAS ACCESSED TO USE A DIFFERENT AR-9597-20 ANGLED REAMER SLEEVE TO COMPLETE THE PROCEDURE SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21112659 ↗MalfunctionJan 8, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 12/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9676 ANGLED REAMER DRIVE SHAFT WAS WELDED TOGETHER WITH THE AR-9597-20 ANGLED REAMER SLEEVE, 20° AND CAUSED THE SURGEON'S WRIST TO SUDDENLY TWIST AND MAKES THE REAMING DIFFICULT. A SECOND AR-9597-20 ANGLED REAMER SLEEVE, 20°, WAS USED, AND THE INCIDENT OCCURRED A SECOND TIME. THE CASE WAS CARRIED OUT SUCCESSFULLY WITH A DIFFERENT REAMER SLEEVE AND DRIVESHAFT. THIS WAS DISCOVERED DURING AN RTSA PROCEDURE ON 12/10/2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 12/17/2024: THERE WAS NO CASE DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21102979 ↗MalfunctionDec 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 11/15/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9676 ANGLED DRIVE SHAFT HAS A BURR ON THE SHAFT, CAUSING IT TO GET STUCK IN THE AR-9597-20 SLEEVE. AN AR-9625 HEX DRIVER IS TWISTED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20917635 ↗MalfunctionNov 15, 2024Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking
ON 11/07/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9597-20 ANGLED REAMER SHAFT FUSED TO THE HANDLE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20694837 ↗MalfunctionNov 5, 2024Mechanical Jam; Mechanical Jam
ON 10/23/2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS-06693573 THAT AN AR-9676 ANGLED REAMER, AND AN AR-9597-20 ANGLED REAMER SLEEVE COLD WELDED TOGETHER. THIS OCCURRED DURING A CASE THAT WAS COMPLETED USING NEW DEVICES. THIS RESULTED IN A 30-MINUTE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20613012 ↗MalfunctionNov 1, 2024Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking
ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-9597-20 ANGLED REAMER SLEEVE AND AN AR-9676 ANGLED REAMER DID NOT REAM SMOOTHLY TOGETHER WHILE REAMING THE GLENOID. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY THE SURGEON'S WRIST WOULD TWIST AGGRESSIVELY DURING THE CASE WHILE USING THE POWER. THE CASE CARRIED ON AND WAS COMPLETED SUCCESSFULLY WITH BACKUP PARTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20588265 ↗MalfunctionNov 1, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 10/18/2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-9597-20 ANGLED REAMER SLEEVE, AND AN AR-9676 ANGLED REAMER WELDED TOGETHER WHILE REAMING THE GLENOID. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY, THE CASE CARRIED ON AND WAS COMPLETED SUCCESSFULLY WITH BACK UP PARTS.
Patient problems: Insufficient Information
MAUDE report 20587425 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.