FDAClass IIApril 6, 2022

EasyFuse Dynamic Compression System Instrument Pack recall

EasyFuse Dynamic Compression System Instrument Pack

Why was EasyFuse Dynamic Compression System Instrument Pack recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
EasyFuse Dynamic Compression System Instrument Pack
Recalling firm
Wright Medical Technology, Inc.
Quantity
176 packs
Distribution
US distribution to Florida, North Carolina, Ohio, and Texas
Recall date
April 6, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls