Device product

EasyFuse Dynamic Compression System Instrument Pack

Z-0853-2022

March 10, 2022

Class II

Product summary

Firm: Wright Medical Technology, Inc.
Event: Event 89739
Status: Terminated
Classification: Class II
Quantity: 176 packs
Official record key: device-enforcement:Z-0853-2022

Official wording

Reason: The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.

Code information: Model Number FFSP1530, UDI: 00889797103565 Lot Codes (Expiration Date): 781853-110321 (11/03/2029) and 780395-112221 (12/03/2029)

Distribution pattern: US distribution to Florida, North Carolina, Ohio, and Texas

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.