BIOKNOTLESS PANACRYL ETHIBONDRecalls & reported problems across all models
Depuy Mitek, LLC · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one BIOKNOTLESS PANACRYL ETHIBOND model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 2
We found 3 models of BIOKNOTLESS PANACRYL ETHIBOND by Depuy Mitek, LLC in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Jun 19, 2018 and Jun 14, 2023 — classified as 1 injury, 34 malfunctions.
The most frequently reported specific device problem is “Break” (30 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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
BIOKNOTLESS PANACRYL ETHIBOND 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.
- Apr 13, 2023Open, Classified
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
Z-1681-2023 · Root cause: Use error · Recall details · FDA record ↗
- Apr 13, 2023Open, Classified
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
Z-1678-2023 · Root cause: Use error · Recall details · FDA record ↗
Most reported BIOKNOTLESS PANACRYL ETHIBOND problems
Device problems
- Break30
- Migration3
- Material Frayed1
- Material Twisted/Bent1
Patient problems
- Foreign Body In Patient22
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient2
- Not Applicable1
- Unspecified Tissue Injury1
BIOKNOTLESS PANACRYL ETHIBOND models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BIOKNOTLESS PANACRYL ETHIBOND 212723Suture, nonabsorbable, synthetic, polyester1 recall33 reports
- BIOKNOTLESS PANACRYL ETHIBOND 212725FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall1 report
- BIOKNOTLESS PANACRYL ETHIBOND 212739STAPLE, FIXATION, BONE1 report
Recent BIOKNOTLESS PANACRYL ETHIBOND adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 14, 2023Break; Break
IT WAS REPORTED BY THE AFFILIATE IN UNITED KINGDOM THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, A BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE WAS USED. ACCORDING TO THE REPORT, IT WAS CONFIRMED FOLLOWING A REVIEW OF IMAGING THAT RETAINED METAL FRAGMENT TIPS FROM THE INTRODUCER REMAINED IN THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 17126068 ↗MalfunctionMay 9, 2023Break; Break
IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN UNITED KINGDOM THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, A BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE WAS USED. ACCORDING TO THE REPORT, FOLLOWING A REVIEW OF IMAGING, IT WAS CONFIRMED THAT THERE WERE METAL FRAGMENT TIPS FROM THE INTRODUCER THAT REMAINED IN THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 16897342 ↗MalfunctionMay 8, 2023Break; Break
IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN UNITED KINGDOM THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, A BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE WAS USED. ACCORDING TO THE REPORT, POSTOPERATIVELY A REVIEW OF IMAGING, CONFIRMED RETAINED METAL FRAGMENT TIPS FROM THE INTRODUCER THAT REMAINED IN THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 16889682 ↗MalfunctionFeb 7, 2023Migration; Migration
IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN UNITED KINGDOM THAT POSTOPERATIVELY TO AN UNKNOWN PROCEDURE USING A ,BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE, THE PATIENT EXPERIENCED METAL FRAGMENTS MIGRATION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 16313089 ↗MalfunctionFeb 7, 2023Migration; Migration
IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN UNITED KINGDOM THAT POSTOPERATIVELY TO AN UNKNOWN PROCEDURE USING A ,BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE, THE PATIENT EXPERIENCED METAL FRAGMENTS MIGRATION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 16313069 ↗MalfunctionJan 10, 2023Break; Break
THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 16132866 ↗MalfunctionJan 10, 2023Break; Break
THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 16132864 ↗MalfunctionJan 10, 2023Break; Break
THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 16132862 ↗MalfunctionJan 10, 2023Break; Break
THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 16132777 ↗MalfunctionJan 10, 2023Break; Break
THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 16132775 ↗MalfunctionJan 10, 2023Break; Break
THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 16132750 ↗MalfunctionJan 10, 2023Break; Break
THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 16132749 ↗MalfunctionJan 10, 2023Break; Break
THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 16132747 ↗MalfunctionJan 10, 2023Break; Break
THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 16132691 ↗MalfunctionJan 10, 2023Break; Break
THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 16132684 ↗
Other Depuy Mitek, LLC products
All Depuy Mitek, LLC devices →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.
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