EBI XFIX DFS Rail System — Class II medical device recall Z-0527-2013
Terminated recall by Biomet, Inc., reported 2012-12-26, distributed in CA, FL, MI, NY, PA, TN, TX. It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.
| Recall number | Z-0527-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2012-11-09 |
| Classified | 2012-12-17 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2013-08-28 |
| Distributed | CA, FL, MI, NY, PA, TN, TX |
| Countries outside the US | JP |
| Quantity | 49 |
| Model numbers | 06350 |
Product
EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures.
Reason for recall
It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.
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-0527-2013. 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.