Vanguard Knee System PS Tibial Bearing — Class II medical device recall Z-2183-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-06-20, distributed nationwide. The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, a
| Recall number | Z-2183-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-05-11 |
| Classified | 2018-06-13 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2019-11-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 169 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00880304673885 |
| Lot numbers | 120150, 140700, 173480, 205730, 294370, 338750, 421970, 516680, 678370, 700470, 722060, 775330, 858220, 888080, 992290 |
| Model numbers | 183621 |
Product
Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
Reason for recall
The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.
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-2183-2018. 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.