Z-1006-2019Class II

NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws...

Name: Z-1006-2019 NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws...
Creator: Zimmer Trabecular Metal Technology, Inc.
Published: 2019-02-01
License: https://open.fda.gov/license/

Zimmer Trabecular Metal Technology, Inc. / initiated 2019-02-01 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Trabecular Metal Technology, Inc. began a recall of NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 Product Usage: The... on 2019-02-01. FDA classified it as Class II and gives the reason as "Potentially comingled, resulting in the product in the box potentially not matching the product on the label". 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-1006-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-01
Posted: 2019-03-11
Terminated: 2020-05-15
Recalling firm: Zimmer Trabecular Metal Technology, Inc.
Product: 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.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Potentially comingled, resulting in the product in the box potentially not matching the product on the label
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
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.
Quantity in commerce: 26 units
Distribution: 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
Product codes and lots: Lot Numbers: 63244259 63247617 63279968 61581585T (01) 00889024307902 (17) 210131 (10) 63244259 (01) 00889024307902 (17) 210228 (10) 63247617 (01) 00889024307902 (17) 210228 (10) 63279968 (01) 00889024307902 (17) 210228 (10) 61581585T

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1006-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1005-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-11
Z-1006-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-11

Product code JWH

K024161Class IINexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. / cleared 2003-01-15

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)