Comprehensive VRS Inserter — Class II medical device recall Z-2300-2020
Terminated recall by Biomet, Inc., reported 2020-06-17, distributed nationwide. The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, wh
| Recall number | Z-2300-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2020-05-11 |
| Classified | 2020-06-08 |
| Reported by FDA | 2020-06-17 |
| Terminated | 2020-11-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | NL |
| Quantity | 38 |
| UPC / GTIN / UDI-DI | 00880304829503 |
| Lot numbers | 570640, 728890, 814100, 977300 |
| Model numbers | 110019068 |
Product
Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100, (01)00880304829503 (10)570640, (01)00880304829503 (10)728890, (01)00880304829503 (10)977300
Reason for recall
The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement 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-2300-2020. 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.