Unilateral external fixation ankle clamp Product Usage: Unilateral… — Class II medical device recall Z-1741-2015
Terminated recall by Biomet, Inc., reported 2015-06-17, distributed nationwide. Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. This prevents com
| Recall number | Z-1741-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2015-05-01 |
| Classified | 2015-06-09 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2015-12-08 |
| Distributed | Nationwide (US) |
| Quantity | 19 |
| Lot numbers | 268000, 466170, 813950 |
| Model numbers | 14-450510, 466170, 813950 |
Product
Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality
Reason for recall
Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. This prevents complete range of motion and if pushed too far may loosen the pin from the bone. A revision surgery may be necessary to adequately reconnect the fixator to the bone.
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-1741-2015. 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.