Comprehensive Reverse Shoulder System — Class II medical device recall Z-0619-2021
Terminated recall by Biomet, Inc., reported 2020-12-23, distributed nationwide. Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packa
| Recall number | Z-0619-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2020-11-25 |
| Classified | 2020-12-17 |
| Reported by FDA | 2020-12-23 |
| Terminated | 2024-05-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CL, CN, CR, HK, IN, JP, KR, MY, NZ, SG, TW |
| Quantity | 7,428 |
| Reason classes | sterility, packaging |
| Lot numbers | 154290, 154300, 154360, 154420, 154430, 155060, 193140, 193200, 193220, 193300, 208000, 208010, 208130, 208270, 214470, 214490, 214500, 214520, 214610, 214630, 214640, 214650, 214660, 214700, 214710, 214720, 214730, 214740, 214750, 214760, 270240, 270260, 270290, 270300, 270310, 272150, 272290, 272530, 272620, 272680 and 55 more |
| Model numbers | 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 |
Product
Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthroplasty and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff The patient must anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
Reason for recall
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
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-0619-2021. 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.