Zimmer Compress Devices and Instruments recall
Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device…
Why was Zimmer Compress Devices and Instruments recalled?
Correction to update the surgical technique for the Compress System. To make users aware of the changes that were made only to the selection criteria section on page 42 regarding which array to use in the placement of the anti-rotation pins.
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?
All
- Product
- Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device…
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 323 devices US; 208 distributed OUS
- Distribution
- Nationwide Foreign: CANADA ARGENTINA AUSTRALIA BELGIUM CHILE FINLAND JAPAN NETHERLANDS
- Recall date
- December 26, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)