Comprehensive Reverse Shoulder Instrument Case Total — Class II medical device recall Z-1961-2019
Terminated recall by Zimmer Biomet, Inc., reported 2019-07-24, distributed nationwide. Lack of an adequate sterilization validation.
| Recall number | Z-1961-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2019-06-10 |
| Classified | 2019-07-12 |
| Reported by FDA | 2019-07-24 |
| Terminated | 2020-09-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CA, CL, CN, CR, EC, IN, JP, KR, MX, MY, NL, TH, VE |
| Quantity | 1,257 |
| Lot numbers | 1081211, 1411303, 1631512, 1641404, 171421, 1721312, 1951228, 1961120, 203752, 21110105, 21110106, 21110107, 21110108, 21110117, 2111048, 2111050, 2111051, 2111052, 2261523, 2291016, 2291017, 2331407, 251059, 254986, 260646, 263012, 2631048, 2631353, 264753, 2681520, 2881019, 2981046, 3181203, 3231032, 3341019, 3461146, 443894, 476977, 501920, 530934 and 11 more |
| Model numbers | 595510 |
Product
Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
Reason for recall
Lack of an adequate sterilization validation.
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-1961-2019. 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.