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Terminated

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.

FDA Recall Z-1325-2015 · Posted 2015-03-26

Recalling FirmZimmer Trabecular Metal Technology, Inc.
Recall StatusTerminated
Product CodeMBH
Date Initiated2015-02-04
Date Terminated2015-07-16
Product Quantity1 unit

Reason for Recall

One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.

Firm Action

Zimmer Trabecular Metal Technology sent an email dated 12/10/2014 to their sole customer. The customer was requested to return the affected product.

Root Cause

Error in labeling

Distribution Pattern

US Distribution in the state of CA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040487TRABECULAR METAL KNEE SYSTEM AUGMENTSImplex Corp. · 2004-12-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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