MODIFIED/SPECIAL INSTRUMENT — Class II medical device recall Z-3102-2017
Terminated recall by Encore Medical, Lp, reported 2017-09-06, distributed in OH, VA. It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to create the sp
| Recall number | Z-3102-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, Lp, Austin, TX, United States |
| Recall initiated | 2017-08-04 |
| Classified | 2017-08-30 |
| Reported by FDA | 2017-09-06 |
| Terminated | 2023-06-28 |
| Distributed | OH, VA |
| Quantity | 5 units |
| Lot numbers | 535U1000, 536U1000, 537U1000, S-200956, S-200957, S-200958 |
| Model numbers | 200956, 200957, 200958, 5MMPIN |
Product
MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58
Reason for recall
It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to create the spherical radius cutting surface. Device design allows a larger spherical radius cutting surface than intended.
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-3102-2017. 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.