Recap Hip System US157348Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
2 other recalls cover devices cleared under the same FDA submission (K071053, K992367); they may or may not involve this specific model.
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.
Recalls naming this device
- Aug 21, 2019Terminated
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Z-0523-2020 · Root cause: Environmental control · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K071053, K992367. One submission often covers many models, so check the product and lot details in each record.
- Z-0528-2020 · Aug 21, 2019 · TerminatedHA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA
- Z-1823-2016 · Apr 1, 2016 · TerminatedVarious trauma and sports medicine instruments and implants. Screw, fixation, bone.
Other Prosthesis, hip, femoral, resurfacing devices
- SYNOVO HIP COMPONENTS 01-03-0044Synovo Production · Prosthesis, Hip, Femoral, Resurfacing1 recall0 reports
- Recap Hip System US157340Biomet Orthopedics, LLC · Prosthesis, hip, femoral, resurfacing1 recall0 reports
- Recap Hip System US157344Biomet Orthopedics, LLC · Prosthesis, hip, femoral, resurfacing1 recall0 reports
- SYNOVO HIP COMPONENTS 01-03-0047Synovo Production · Prosthesis, Hip, Femoral, Resurfacing1 recall0 reports
- Recap Hip System US157342Biomet Orthopedics, LLC · Prosthesis, hip, femoral, resurfacing1 recall0 reports
- Recap Hip System US157346Biomet Orthopedics, LLC · Prosthesis, hip, femoral, resurfacing1 recall0 reports
- SYNOVO HIP COMPONENTS 01-03-0045Synovo Production · Prosthesis, Hip, Femoral, Resurfacing1 recall0 reports
- Recap Hip System US157356Biomet Orthopedics, LLC · Prosthesis, hip, femoral, resurfacing1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.