FDA Device

NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 Product Usage: The Trabecular Metal Tibial Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution Rotating Hinge Knee (RHK) System, the Trabecular Metal Tibial Cone Augments are for cemented use only. When used with the NexGen Com

Hazard

Potentially comingled, resulting in the product in the box potentially not matching the product on the label

What You Should Do

Remedy

Zimmer Biomet notified sent an Urgent Medical Device Recall on February 1, 2019 via email and Fed'X letter to Distributors, hospitals and surgeons, The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately locate and quarantine affected product in your inventory, complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com. For questions contact Customer Service at 574-371-3071.

Products

NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 Product Usage: The Trabecular Metal Tibial Cone Augments are inten
Brand
Zimmer Trabecular Metal Technology, Inc.
UPC
Lot Numbers:  63253751 63257915 63291542 UDI:  (01) 00889024307858 (17) 210228 (10) 63253751 (01) 00889024307858 (17) 210228 (10) 63257915 (01) 00889024307858 (17) 210430 (10) 63291542

Units Affected

24 units