Recall Z-1325-2015— Zimmer Trabecular Metal Technology, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Trabecular Metal Technology, Inc., initiated 2015-02-04, terminated 2015-07-16. It names one FDA 510(k) clearance: K040487. Product: NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: 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 Augments are for cemented use only. When used with the NexGen Complete Knee Solution-Legacy Constrained Condylar Knee System, the Trabecular Metal Augments are for cementless or cemented use.. Reason: One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed..
- Recalling firm
- Zimmer Trabecular Metal Technology, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-02-04
- Terminated
- 2015-07-16
- Firm location
- Parsippany, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: 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 Augments are for cemented use only. When used with the NexGen Complete Knee Solution-Legacy Constrained Condylar Knee System, the Trabecular Metal Augments are for cementless or cemented use.
Reason for recall
One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.