FDA Device recall Z-1312-2016
Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument
- FDA Device
- Class II
- terminated
- Published 2016-04-06
On 2016-04-06 the FDA classified a Class II recall of Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument by Synthes Usa Products, citing dePuy Synthes is initiating a voluntary medical device recall of certain lots of the Interlocking Bolt which are a part of the Synthes 4.5 mm LCP Proximal Tibia Plate System. The….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1312-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-16 |
| Published | 2016-04-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
Product
Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument
Reason
DePuy Synthes is initiating a voluntary medical device recall of certain lots of the Interlocking Bolt which are a part of the Synthes 4.5 mm LCP Proximal Tibia Plate System. The Synthes 4.5 mm LCP Proximal Tibia Plate are indicated for the treatment of nonunions, malunions and fractures of the proximal tibia including: simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combi
Identifiers
| code_info | Lot Number# 1776197 (5706588), 1782340 and 1868678 Catalog ID 03.120.027 For lot 1776197, the part is etched with 177…Lot Number# 1776197 (5706588), 1782340 and 1868678 Catalog ID 03.120.027 For lot 1776197, the part is etched with 1776197; the package label documents 5706588. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1312-2016%22
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