Z-0853-2022 Class II Terminated

Recalled by Wright Medical Technology, Inc. — Memphis, TN

FDA device recall Z-0853-2022 was initiated by Wright Medical Technology, Inc. on Mar 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 Apr 1, 2026). Affected quantity: 176 packs.

Recall Details

Product Type
Devices
Report Date
Apr 6, 2022
Initiation Date
Mar 10, 2022
Termination Date
Apr 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)

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0853-2022
openFDA file date
Nov 3, 2026
Loaded by RegDataLab
Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for Z-0853-2022. Report a data issue: hello@regdatalab.com.