GPSRecalls & reported problems across all models

We found 6 models of GPS by Exactech, Inc. in the FDA's device registry (GUDID). Together they are named in 9 adverse event reports in the FDA's MAUDE database, received between Oct 11, 2019 and Jul 25, 2025 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

GPS recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 5, 2023Class IIOpen, Classified

   The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.

   Z-2050-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported GPS problems

GPS models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GPS 531-07-05

  System, image processing, radiological
  1 recall2 reports
• GPS 531-25-00

  System, image processing, radiological
  2 reports
• GPS 531-01-03

  System, image processing, radiological
  2 reports
• GPS 531-78-20

  Orthopedic manual surgical instrument
  1 report
• GPS 531-20-00

  System, image processing, radiological
  1 report
• GPS 531-01-04

  Orthopedic stereotaxic instrument
  1 report

Recent GPS adverse event reports

The 9 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED A SCAPULAR FRACTURE DURING IMPLANTATION OF DEVICES. DRILLING CENTER CAGE FOR ANATOMIC BASE PLATE, DRILL CAUGHT SCAPULAR VAULT AND FRACTURED GLENOID AT PIN SITE. AS A RESULT, THE PATIENT WAS CONVERTED TO RTSA INTRA-OP WITHOUT ISSUE. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 22613389 ↗
• MalfunctionApr 18, 2022Break; Break

  IT WAS REPORTED FROM THE US THAT DURING AN ANATOMIC SHOULDER SURGERY THE MODULAR DRIVER TIP SHEARED OFF WHILE SURGEON WAS REAMING GLENOID. THERE WERE NO PARTS OR PIECES FELL INTO THE SURGICAL SITE. THERE WAS NO DELAY OR ADVERSE EVENT TO THE PATIENT. THE PATIENT¿S HEALTH WAS STABLE LEAVING THE OR. PATIENT DEMOGRAPHIC INFORMATION WAS NOT PROVIDED. THE AGENT WAS PRESENT AT THE TIME OF SURGERY. MULTIPLE EMAIL REQUESTS WERE SENT TO THE CONTACTS FOR ADDITIONAL INFORMATION. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE CONTACTS RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135849 ↗
• MalfunctionFeb 7, 2022Break; Break

  IT WAS REPORTED THAT THE BALL BEARING AND SPRING FROM THE GPS GLENOID IMPACTOR HANDLE DISLODGED INSIDE OF PATIENT WHEN THE SURGEON IMPACTED THE GLENOID BASEPLATE. THE SURGEON BECAME AWARE WHEN THE SPRING WAS LOCATED DURING THE CASE. POST OP AP X RAY TAKEN SHOWS NO BALL BEARING LEFT IN THE PATIENT. THERE WAS LESS THAN A 5 MINUTE SURGICAL DELAY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 13476909 ↗
• MalfunctionMar 17, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGICAL USE, THE TIP BROKE OFF THE DRIVER HANDLE WHILE REAMING. IT APPEARED TO GET CAUGHT ON RETRACTOR. NO PIECES FELL INTO THE PATIENT. THERE WAS NO SURGICAL DELAY AND THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11507314 ↗
• MalfunctionFeb 24, 2021Break; Break

  AS REPORTED, THE STERILE PROCESSING STAFF MEMBER RECEIVED THE BASEPLATE STILL ATTACHED TO THE HANDLE. WHEN ATTEMPTING TO SEPARATE THE 2 PIECES, THE BALL BEARING SECURING THE SPRING AND LOCKING MECHANISM OF THE BASEPLATE HAS DROPPED OUT. THIS WAS DONE TO WASH THE INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT AND THE DEVICES ARE RETURNING.

  Patient problems: No Patient Involvement

  MAUDE report 11371607 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE BASE OF THE PATIENT¿S CORACOID BONE WAS FRACTURED. MOST LIKELY FROM THE SCREWS USED TO ATTACHED THE ¿G¿ TRACKER ONTO THE CORACOID. THIS WAS DISCOVERED PRIOR TO DRILLING THE COMPRESSION SCREWS INTO THE REVERSE BASEPLATE. THERE WAS NO SURGICAL DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 10837228 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE CLINICAL DATA STUDY BASE, A (B)(6) Y/O FEMALE PATIENT PRESENTED FOR A 6-WEEK POSTOP L TSA EXAM AND A CORACOID FRACTURE WAS NOTED. THERE WAS NO ADDITIONAL TREATMENT FOR THE FRACTURE. IT IS UNKNOWN WHEN THE FRACTURE OCCURRED, HOWEVER, THE AE REPORT FROM THE STUDY STATES ¿POST-OP¿. THE PATIENT HAS A HISTORY OF OSTEOARTHRITIS AND HYPERTENSION. IT IS NOTED THAT AUTOGRAFT WAS USED BEHIND THE BASEPLATE DURING THE PROCEDURE AND GPS NAVIGATION WAS ALSO USED DURING THE PROCEDURE. PATIENT OUTCOME WAS NOTED AS ¿CONTINUING¿. THERE ARE NO DEVICES TO BE RETURNED.

  Patient problems: Bone Fracture(s)

  MAUDE report 10559589 ↗
• InjuryOct 11, 2019Break; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A TSA PROCEDURE, THE SURGEON PLACED HEX PINS IN THE CORACOID TO FIX THE CORACOID BLOCK TO THE CORACOID. THE SURGEON WAS AWARE THAT THIS PATIENT HAD POOR BONE QUALITY. DURING THE GLENOID REGISTRATION, THE PATIENT'S CORACOID BROKE. THE CORACOID BLOCK AND TRACKER COULD NOT BE REATTACHED SINCE THERE WAS INSUFFICIENT CORACOID BONE LEFT. THE PROCEDURE CONTINUED WITH THE REVERSE SHOULDER WITHOUT GPS AND THE CASE WENT WELL.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9181645 ↗
• InjuryOct 11, 2019Break; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A TSA PROCEDURE, THE SURGEON PLACED HEX PINS IN THE CORACOID TO FIX THE CORACOID BLOCK TO THE CORACOID. THE SURGEON WAS AWARE THAT THIS PATIENT HAD POOR BONE QUALITY. DURING THE GLENOID REGISTRATION, THE PATIENT¿S CORACOID BROKE. THE CORACOID BLOCK AND TRACKER COULD NOT BE REATTACHED SINCE THERE WAS INSUFFICIENT CORACOID BONE LEFT. THE PROCEDURE CONTINUED WITH THE REVERSE SHOULDER WITHOUT GPS AND THE CASE WENT WELL.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9181579 ↗

Other Exactech, Inc. products

• Equinoxe305 models · 2,076 reports · 37 recalls
• Optetrak Logic408 models · 3,306 reports · 3 recalls
• Novation184 models · 1,145 reports · 25 recalls
• Optetrak336 models · 1,773 reports · 6 recalls
• Truliant414 models · 1,010 reports · 2 recalls
• Acumatch A Series94 models · 54 reports · 15 recalls
• MCS25 models · 7 reports · 5 recalls
• Alteon135 models · 100 reports · 3 recalls