Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.
Hazard
It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
What You Should Do
A Recall notification letter titled, "URGENT: RECALL NOTIFCIATION" was sent to consignees on 03/11/2021 via email. The email sent to the consignees requested that the parts be returned. Additionally, the firm is currently awaiting all distributed units to be returned. The recalling firm requested that consignees immediately discontinue use, sale, and distribution of the product. Instructions were provided for Arthrex Agencies (North America), Arthrex Subsidiaries (LATAM and APAC), direct customers (EMEA), and Arthrex Subsidiaries (EMEA) as follows: Arthrex Agencies (North America): Please contact Arthrex Product Surveillance at 866-267-9138 or complaints@arthrex.com. The consignee is not required to notify patients of the product recall. Arthrex Subsidiaries (LATAM and APAC): Please contact Arthrex Product Surveillance at 866-267-9138 or complaints@arthrex.com. The consignee is not required to notify patients of the product recall. Direct customers (EMEA): Please contact Arthrex Product Surveillance at +49 89 90 90 05 5240 or complaints@arthrex.com. The consignee is not required to notify patients of the product recall. Arthrex Subsidiaries (EMEA): Please contact Arthrex Product Surveillance at +49 89 90 90 05 5240 or complaints@arthrex.com. The consignee is not required to notify patients of the product recall.
Get a free legal consultation about this recall.
Talk to a Lawyer →Affiliate link
Products
- Brand
- Arthrex, Inc.
- UPC
- Part number: AR-13200T-15.0; Lot code:12135408
Units Affected
32 units