FDA Device recall Z-0167-2016
2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm
- FDA Device
- Class II
- terminated
- Published 2015-11-04
On 2015-11-04 the FDA classified a Class II recall of 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm by Synthes Usa Products, citing specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0167-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-06 |
| Published | 2015-11-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Products |
| Distribution | TN |
Product
2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.
Reason
Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.
Identifiers
| code_info | Part Number 202.212 Lot Number 3420620 |
|---|
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-0167-2016%22
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