AltiVate Reverse INSTRUMENTATION — Class II medical device recall Z-1241-2018
Terminated recall by Encore Medical, Lp, reported 2018-04-04, distributed nationwide. Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the
| Recall number | Z-1241-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, Lp, Austin, TX, United States |
| Recall initiated | 2018-01-30 |
| Classified | 2018-03-28 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2023-05-30 |
| Distributed | Nationwide (US) |
| Quantity | 387 units |
| Reason classes | potency |
| Lot numbers | 183312L03, 200006L01, 224643L01 |
| Model numbers | 804-06-152 |
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.
Reason for recall
Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1241-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.