Vanguard Complete Knee System — Class II medical device recall Z-2289-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-07-04, distributed in CA, CT, GA, IA, IN, LA, MA, MD…. Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in
| Recall number | Z-2289-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-05-24 |
| Classified | 2018-06-26 |
| Reported by FDA | 2018-07-04 |
| Terminated | 2020-04-07 |
| Distributed | CA, CT, GA, IA, IN, LA, MA, MD, MN, MS, NJ, OH, PA, TN, TX, UT, VA, WI |
| Countries outside the US | JP, NL, TW |
| Quantity | 48 |
| Reason classes | labeling |
| Lot numbers | 198810, 210320 |
| Model numbers | EP-183642, EP-183664 |
Product
Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The product is intended for use in knee joint replacement arthroplasties.
Reason for recall
Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant.
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-2289-2018. 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.