Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.
- Company
- Arthrex, Inc.
- Recall Initiated
- June 24, 2020
- Terminated
- February 16, 2021
- Recall Number
- Z-2733-2020
- Quantity
- 28 units
- Firm Location
- Naples, FL
Reason for Recall
Screws provided in packaging are 5mm shorter than intended
Distribution
International distribution in the countries of Denmark, United Kingdom, Sweden, Japan, Netherlands
Lot / Code Info
Batch Number: 10706233 UDI Number:00888867056411
Root Cause
Process control
Action Taken
Arthrex initiated recall on 06/24/2020. The notification states the following: 1 . Immediately discontinue use, sale, and distribution of the product. 2. Direct Customers (EMEA): a. Please contact Arthrex Product Surveillance at +49 89 9090 05 5240 or complaints@arthrex.de. Arthrex Product Surveillance Specialists are available to answer questions regarding credit for affected devices in your possession. b. You do not need to notify any patients of this product recall. 3. Arthrex Subsidiaries (EMEA): a. Please contact Arthrex Product Surveillance at +49 89 9090 05 5240 or complaints@arthrex.de. Arthrex Product Surveillance Specialists are available to answer questions regarding credit for affected devices in your possession. b. You do not need to notify any patients of this product recall. 4. Arthrex Subsidiaries (APAC): a. Please contact Arthrex Product Surveillance at 866-267-9138 or complaints@arthrex.com. Arthrex Product Surveillance Specialists are available to answer questions regarding credit for affected devices in your possession. b. You do not need to notify any patients of this product recall. 5. If you have any questions about this product recall, please contact Arthrex Product Surveillance at 866-267-9138 or complaints@arthrex.com.