FDA Device recall Z-0527-2013
EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp)
- FDA Device
- Class II
- terminated
- Published 2012-12-26
On 2012-12-26 the FDA classified a Class II recall of EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp) by Biomet, citing it was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0527-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-09 |
| Published | 2012-12-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet |
| Distribution | CA, FL, MI, NY, PA, TN, TX |
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
It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.
Identifiers
| code_info | Catalog Number 06350 and Lot Number Identification 994790 (packaged as 042210) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Biomet
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm
FDA Device · Class II · 2026-08-12 · Biomet - Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm
FDA Device · Class II · 2026-08-12 · Biomet - Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm
FDA Device · Class II · 2026-08-12 · Biomet - Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm
FDA Device · Class II · 2026-08-12 · Biomet - Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm
FDA Device · Class II · 2026-08-12 · Biomet
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0527-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.