Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful… — Class II medical device recall Z-0111-2017
Terminated recall by Zimmer Biomet, Inc., reported 2016-10-26, distributed nationwide. Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal Femoral Augment
| Recall number | Z-0111-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2016-08-09 |
| Classified | 2016-10-17 |
| Reported by FDA | 2016-10-26 |
| Terminated | 2017-05-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, SE |
| Quantity | 5 |
| Reason classes | labeling |
| Lot numbers | 183410 |
| Model numbers | 184108 |
| Expiration dates | 2025-08-27 |
Product
Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. Correction of varus, valgus, or posttraumatic deformity. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The device is a single use implant intended for implantation with bone cement.
Reason for recall
Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal Femoral Augment 75 X 5 RL/LM Carton contains: Vanguard Distal Femoral Augment 75 X 5 LL/RM Risks: Adverse health outcomes that could occur as a result of this event are a delay less than 30 minutes and a different size augment being used to complete the procedure. As the augment will not assemble with femoral component due to its shape, it would be easily identified during surgery.
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-0111-2017. 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.