Recall Z-0919-2020
Arthrex, Inc. · initiated December 17, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
Codes / lots: Batch/Lot 051838
Reason for recall
There is a potential for blockage of the Hub Attachment Tube.
FDA-determined cause: Process control
Action taken
Consignees were notified via e-mail with recall letter dated 12/17/2019. The letter identified affected product, reason for recall, and instructed consignee to immediately discontinue use, sale, and distribution of the product as well instructions for handling of affected product.
Details
- Recall number
- Z-0919-2020
- Initiated
- December 17, 2019
- Terminated
- August 31, 2023
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Quantity
- 47
- Distribution
- Nationwide in US; no distribution OUS.
- Recalling firm
- Arthrex, Inc., Naples, FL