NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 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 Complete Knee Solution Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use.
FDA Recall Z-1006-2019 · Posted None
Recalling FirmZimmer Trabecular Metal Technology, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2019-02-01
Date Terminated2020-05-15
Product Quantity26 units
Reason for Recall
Potentially comingled, resulting in the product in the box potentially not matching the product on the label
Firm Action
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 [email protected].
For questions contact Customer Service at 574-371-3071.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Worldwide Distribution - US Nationwide Distribution in the states of AL, CA, CO, ID, MS,NE, NJ, NY, OH, OR, PA, TX, VA, WI and Foreign CANADA, JAPAN, GERMANY , NETHERLANDS
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.