PERMA-HANDRecalls & reported problems across all models
Ethicon, LLC · 77 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one PERMA-HAND model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 664
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls
- 1
We found 77 models of PERMA-HAND by Ethicon, LLC in the FDA's device registry (GUDID). Together they are named in 664 adverse event reports in the FDA's MAUDE database, received between Jan 17, 2018 and Sep 25, 2026 — classified as 25 injuries, 639 malfunctions.
The most frequently reported specific device problem is “Break” (369 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
Reports received per month, all models
PERMA-HAND 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.
- Dec 20, 2024Open, Classified
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
Z-1097-2025 · Root cause: Process control · names 4 of these models · Recall details · FDA record ↗
Most reported PERMA-HAND problems
Device problems
- Break369
- Material Separation171
- Device Contaminated During Manufacture or Shipping25
- Component Misassembled22
- Delivered as Unsterile Product21
- Adverse Event Without Identified Device or Use Problem16
- Device Markings/Labelling Problem13
- Detachment Of Device Component12
Patient problems
- No Clinical Signs, Symptoms or Conditions458
- No Consequences Or Impact To Patient157
- Hemorrhage/Blood Loss/Bleeding19
- Insufficient Information14
- Erythema7
- Inflammation7
- Not Applicable6
- Swelling/ Edema6
PERMA-HAND models
77 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PERMA-HAND SA86GSUTURE, NONABSORBABLE, SILK120 reports
- PERMA-HAND K833HSUTURE, NONABSORBABLE, SILK1 recall46 reports
- PERMA-HAND K872HSUTURE, NONABSORBABLE, SILK1 recall8 reports
- PERMA-HAND W723HSUTURE, NONABSORBABLE, SILK1 recall1 report
- PERMA-HAND 623HSUTURE, NONABSORBABLE, SILK1 recall0 reports
- PERMA-HAND C003DSUTURE, NONABSORBABLE, SILK35 reports
- PERMA-HAND C016DSUTURE, NONABSORBABLE, SILK26 reports
- PERMA-HAND SA87GSUTURE, NONABSORBABLE, SILK26 reports
- PERMA-HAND K942HSUTURE, NONABSORBABLE, SILK24 reports
- PERMA-HAND 640GSUTURE, NONABSORBABLE, SILK21 reports
- PERMA-HAND K870HSUTURE, NONABSORBABLE, SILK21 reports
- PERMA-HAND 680HSUTURE, NONABSORBABLE, SILK20 reports
- PERMA-HAND 683GSUTURE, NONABSORBABLE, SILK20 reports
- PERMA-HAND 632GSUTURE, NONABSORBABLE, SILK19 reports
- PERMA-HAND K834HSUTURE, NONABSORBABLE, SILK19 reports
- PERMA-HAND 685GSUTURE, NONABSORBABLE, SILK17 reports
- PERMA-HAND K846HSUTURE, NONABSORBABLE, SILK15 reports
- PERMA-HAND C012DSUTURE, NONABSORBABLE, SILK13 reports
- PERMA-HAND K832HSUTURE, NONABSORBABLE, SILK13 reports
- PERMA-HAND K952HSUTURE, NONABSORBABLE, SILK13 reports
- PERMA-HAND 641GSUTURE, NONABSORBABLE, SILK12 reports
- PERMA-HAND C013DSUTURE, NONABSORBABLE, SILK11 reports
- PERMA-HAND A182HSUTURE, NONABSORBABLE, SILK8 reports
- PERMA-HAND 424HSUTURE, NONABSORBABLE, SILK7 reports
- PERMA-HAND 1677GSUTURE, NONABSORBABLE, SILK6 reports
- PERMA-HAND A304HSUTURE, NONABSORBABLE, SILK6 reports
- PERMA-HAND C017DSUTURE, NONABSORBABLE, SILK6 reports
- PERMA-HAND C021DSUTURE, NONABSORBABLE, SILK6 reports
- PERMA-HAND 423HSUTURE, NONABSORBABLE, SILK5 reports
- PERMA-HAND 769GSUTURE, NONABSORBABLE, SILK5 reports
- PERMA-HAND A184HSUTURE, NONABSORBABLE, SILK5 reports
- PERMA-HAND K873HSUTURE, NONABSORBABLE, SILK5 reports
- PERMA-HAND K881HSUTURE, NONABSORBABLE, SILK5 reports
- PERMA-HAND K945GSUTURE, NONABSORBABLE, SILK5 reports
- PERMA-HAND 706GSUTURE, NONABSORBABLE, SILK4 reports
- PERMA-HAND 736GSUTURE, NONABSORBABLE, SILK4 reports
- PERMA-HAND K835HSUTURE, NONABSORBABLE, SILK4 reports
- PERMA-HAND K871HSUTURE, NONABSORBABLE, SILK4 reports
- PERMA-HAND W782HSUTURE, NONABSORBABLE, SILK4 reports
- PERMA-HAND W328HSUTURE, NONABSORBABLE, SILK4 reports
- PERMA-HAND W586HSUTURE, NONABSORBABLE, SILK4 reports
- PERMA-HAND 735GSUTURE, NONABSORBABLE, SILK3 reports
- PERMA-HAND 768GSUTURE, NONABSORBABLE, SILK3 reports
- PERMA-HAND 786GSUTURE, NONABSORBABLE, SILK3 reports
- PERMA-HAND C014DSUTURE, NONABSORBABLE, SILK3 reports
- PERMA-HAND C053DSUTURE, NONABSORBABLE, SILK3 reports
- PERMA-HAND K890HSUTURE, NONABSORBABLE, SILK3 reports
- PERMA-HAND M104TSUTURE, NONABSORBABLE, SILK3 reports
- PERMA-HAND N266HSUTURE, NONABSORBABLE, SILK3 reports
- PERMA-HAND SA76GSUTURE, NONABSORBABLE, SILK3 reports
- PERMA-HAND 1689HSUTURE, NONABSORBABLE, SILK2 reports
- PERMA-HAND 485TSUTURE, NONABSORBABLE, SILK2 reports
- PERMA-HAND 678GSUTURE, NONABSORBABLE, SILK2 reports
- PERMA-HAND 685HSUTURE, NONABSORBABLE, SILK2 reports
- PERMA-HAND 707GSUTURE, NONABSORBABLE, SILK2 reports
- PERMA-HAND A185HSUTURE, NONABSORBABLE, SILK2 reports
- PERMA-HAND C004DSUTURE, NONABSORBABLE, SILK2 reports
- PERMA-HAND D7525SUTURE, NONABSORBABLE, SILK2 reports
- PERMA-HAND K883HSUTURE, NONABSORBABLE, SILK2 reports
- PERMA-HAND K891HSUTURE, NONABSORBABLE, SILK2 reports
- PERMA-HAND N271HSUTURE, NONABSORBABLE, SILK2 reports
- PERMA-HAND SA66GSUTURE, NONABSORBABLE, SILK2 reports
- PERMA-HAND 18515GSUTURE, NONABSORBABLE, SILK2 reports
- PERMA-HAND 1588HSUTURE, NONABSORBABLE, SILK1 report
- PERMA-HAND 590HSUTURE, NONABSORBABLE, SILK1 report
- PERMA-HAND 622HSUTURE, NONABSORBABLE, SILK1 report
- PERMA-HAND 679HSUTURE, NONABSORBABLE, SILK1 report
- PERMA-HAND 7733GSUTURE, NONABSORBABLE, SILK1 report
- PERMA-HAND A306HSUTURE, NONABSORBABLE, SILK1 report
- PERMA-HAND C027DSUTURE, NONABSORBABLE, SILK1 report
- PERMA-HAND C054DSUTURE, NONABSORBABLE, SILK1 report
- PERMA-HAND K831HSUTURE, NONABSORBABLE, SILK1 report
- PERMA-HAND K845HSUTURE, NONABSORBABLE, SILK1 report
- PERMA-HAND K882HSUTURE, NONABSORBABLE, SILK1 report
- PERMA-HAND N272HSUTURE, NONABSORBABLE, SILK1 report
- PERMA-HAND SA65HSUTURE, NONABSORBABLE, SILK1 report
- PERMA-HAND SA74HSUTURE, NONABSORBABLE, SILK1 report
Recent PERMA-HAND adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Device Contaminated During Manufacture or Shipping
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50901130 ↗MalfunctionSep 25, 2026Break
It was reported that a patient underwent a general open procedure on (b)(6) 2026 and suture was used. The suture needle tip separated during a procedure. The detached tip was located and accounted for. There was no patient consequence reported. There was 2-3min of surgical delay was reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899609 ↗MalfunctionSep 25, 2026Break
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. A suture needle tip separated during a procedure. The detached tip was located and accounted for. A similar event has occurred previously within the past few weeks. There was 2-3 min of surgical delay was reported. No adverse patient consequences were reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898388 ↗MalfunctionSep 23, 2026Break
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. At 11:00, the patient underwent surgery and the suture knot suddenly broke during hemostasis. Immediately replaced with new suture and successfully completed the sewing. There were no patient consequences reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868963 ↗MalfunctionSep 22, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860767 ↗MalfunctionAug 5, 2026Break
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50147392 ↗MalfunctionAug 5, 2026Break
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50147384 ↗MalfunctionJul 15, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. PRIOR TO USE ON THE PATIENT, IT WAS NOTED THAT THE SUTURE TIES ARE COMING PACKED WITH AN ORANGE STRING TIED AROUND THEM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES, ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25825746 ↗MalfunctionMay 26, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE BROKE OFF FROM THE THREAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25281447 ↗MalfunctionMay 20, 2026Device Markings/Labelling Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. BEFORE USE, IT WAS REPORTED TO THE SALES REP THAT THE STAFF OBSERVED THAT THE DEVICE PACKAGING DID NOT DISPLAY A LOT NUMBER OR AN EXPIRATION DATE. NO PATIENT INVOLVEMENT. DEVICE IS AVAILABLE FOR RETURN.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25228636 ↗MalfunctionMay 20, 2026Device Markings/Labelling Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. BEFORE USE, IT WAS REPORTED TO THE SALES REP THAT THE STAFF OBSERVED THAT THE DEVICE PACKAGING DID NOT DISPLAY A LOT NUMBER OR AN EXPIRATION DATE. NO PATIENT INVOLVEMENT. DEVICE IS AVAILABLE FOR RETURN.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25228635 ↗MalfunctionMay 15, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE ACCOUNT CONTACT THAT DURING A LUXATING PATELLA SURGERY, EVERY TIME THE SURGEON WENT TO GO TIE THE KNOT WITH THE SUTURE, IT WAS BREAKING AND WON'T HOLD A KNOT. EVEN WITH EASY PRESSURE, THE SUTURE STILL BREAKS. DEVICES WILL BE RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25183968 ↗MalfunctionMay 15, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE ACCOUNT CONTACT THAT DURING A LUXATING PATELLA SURGERY, EVERY TIME THE SURGEON WENT TO GO TIE THE KNOT WITH THE SUTURE, IT WAS BREAKING AND WON'T HOLD A KNOT. EVEN WITH EASY PRESSURE, THE SUTURE STILL BREAKS. DEVICES WILL BE RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25183967 ↗MalfunctionMay 5, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED WHILE TYING THE NODE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25086626 ↗MalfunctionMay 1, 2026Break; Material Twisted/Bent
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE IS EASILY BENDED AND BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25058879 ↗
Other Ethicon, LLC products
- Coated VICRYL350 models · 8,555 reports · 1 recall
- STRATAFIX181 models · 7,673 reports · 7 recalls
- PROLENE358 models · 7,292 reports · 2 recalls
- PDS224 models · 2,635 reports · 10 recalls
- MONOCRYL127 models · 2,308 reports · 3 recalls
- ETHILON133 models · 1,680 reports · 1 recall
- DERMABOND PRINEO4 models · 1,099 reports
- ETHIBOND EXCEL134 models · 921 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page