Z-0853-2022 Class II Terminated
FDA device recall Z-0853-2022 was initiated by Wright Medical Technology, Inc. on March 10, 2022 and is designated Class II. Reason for recall: The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking. The recall status is terminated (terminated April 1, 2026). Affected quantity: 176 packs.
Recall Details
- Product Type
- Devices
- Report Date
- April 6, 2022
- Initiation Date
- March 10, 2022
- Termination Date
- April 1, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 176 packs
Product Description
EasyFuse Dynamic Compression System Instrument Pack
Reason for Recall
The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.
Distribution Pattern
US distribution to Florida, North Carolina, Ohio, and Texas
Code Information
Model Number FFSP1530, UDI: 00889797103565 Lot Codes (Expiration Date): 781853-110321 (11/03/2029) and 780395-112221 (12/03/2029)