FDA Device recall Z-2146-2012
djo surgical Screw 6.5 mm, Sz 25mm, low profile
- FDA Device
- Class II
- terminated
- Published 2012-08-15
On 2012-08-15 the FDA classified a Class II recall of djo surgical Screw 6.5 mm, Sz 25mm, low profile by Encore Medical, citing one lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2146-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-16 |
| Published | 2012-08-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Encore Medical |
| Distribution | US |
Product
djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
Reason
One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 25mm.
Identifiers
| code_info | Lot 007A1037, Ref 010-55-25. |
|---|
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-2146-2012%22
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