FDA Device recall Z-0139-2013
6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair
- FDA Device
- Class II
- terminated
- Published 2012-10-31
On 2012-10-31 the FDA classified a Class II recall of 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair by Encore Medical, citing A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also de….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0139-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-28 |
| Published | 2012-10-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Encore Medical |
| Distribution | US |
Product
6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
Reason
A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there were other screws labeled as size 25, but a size 30 screw was inside of the package. It was thought that all of these screws were found in-house and were contained, but it was determined later that on
Identifiers
| code_info | Model Number 10-55-025, Lot Number 006A1057. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0139-2013%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.