Z-1325-2015Class II

NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only

Name: Z-1325-2015 NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only
Creator: Zimmer Trabecular Metal Technology, Inc.
Published: 2015-02-04
License: https://open.fda.gov/license/

Zimmer Trabecular Metal Technology, Inc. / initiated 2015-02-04 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Trabecular Metal Technology, Inc. began a recall of NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Intended for use where severe degeneration... on 2015-02-04. FDA classified it as Class II and gives the reason as "One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1325-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-04
Posted: 2015-03-26
Terminated: 2015-07-16
Recalling firm: Zimmer Trabecular Metal Technology, Inc.
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.
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
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.
Quantity in commerce: 1 unit
Distribution: US Distribution in the state of CA
Product codes and lots: 20 MM - Part No. 00-5490-034-24, Lot #613574282T 5 MM - Part No. 00549003410, Lot #61357484T

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1325-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1325-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-01	2015-03-26

Product code MBH

K040487Class IITrabecular Metal Knee System AugmentsImplex Corp. / cleared 2004-12-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)