Recall Z-1312-2016— Synthes (USA) Products LLC
Class II · Terminated
Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2016-02-16, terminated 2016-12-07. FDA's recall record names no specific 510(k) clearance for this event. 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.
- Recalling firm
- Synthes (USA) Products LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-16
- Terminated
- 2016-12-07
- Firm location
- West Chester, PA, United States
Product description
Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument
Reason for recall
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
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