Device product
AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard Shell Humeral Stem implants. It assembles to the humeral broaches by a screw in order to replicate/trial the entire humeral stem implant geometry prior to implantation.
Z-1241-2018
Product summary
- Event
- Event 79353
- Status
- Terminated
- Classification
- Class II
- Quantity
- 387 units
- Official record key
device-enforcement:Z-1241-2018
Official wording
Reason: Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.
Code information: Lot Codes: 183312L03, 200006L01, 224643L01
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.