Z-0851-2015Class II

NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green /...

Name: Z-0851-2015 NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green /...
Creator: Zimmer Trabecular Metal Technology, Inc.
Published: 2014-12-02
License: https://open.fda.gov/license/

Zimmer Trabecular Metal Technology, Inc. / initiated 2014-12-02 / Terminated / root cause: design

FDA source

Zimmer Trabecular Metal Technology, Inc. began a recall of NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, UK Zimmer Trabecular... on 2014-12-02. FDA classified it as Class II and gives the reason as "During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0851-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-02
Posted: 2014-12-23
Terminated: 2015-08-28
Recalling firm: Zimmer Trabecular Metal Technology, Inc.
Product: NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, UK Zimmer Trabecular Metal Technology, Inc 10 Pomeroy Road, Parsippany, NJ 07054 USA
Product code: HXB Probe
Reason for recall: During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle.
Root cause tag: design
FDA root cause: Device Design
Action: Zimmer, Inc. sent recall letters/ hospital risk managers emails and letters via courier service on December 2, 2014. Inventory Return Certification Forms were also provided. Your responsibilities are: 1. Locate all products from the identified lot above and quarantine them immediately. 2. Carry out a physical count of all affected product in your territory and complete the Inventory Return Certification Form (Attachment 1), and email a completed copy of Attachment 1 to [email protected]. 3. Return the recalled product along with the completed Inventory Return Certification Form (Attachment 1) to the specified address. 4. Please note that any hospitals that received direct shipments of this product from Zimmer will be sent a copy of the Risk Manager letter directly. 5. Please notify Zimmer of any hospitals that you have further distributed the affected product to. Supply the information for any hospitals that you have identified, as well as the affected surgeons using the provided spreadsheet template. Zimmer will notify the additional surgeons and hospitals you identify via Fed Ex mailing. The template will be emailed to you for completion and return to [email protected]. 6. Ensure that a copy of the Risk Managers letter is left with the facilities from which product is removed by providing them with a copy of the letter, if they are not identified as a facility receiving a letter directly from Zimmer. 7. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST. Biomet emailed a new letter with correct distribution dates on 1/16/2015.
Quantity in commerce: 8 units
Distribution: Worldwide Distribution - US Distribution and the countries of Australia and Denmark.
Product codes and lots: Part number 00-5887-045-00 Lot number 62592928

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0851-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0851-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-23

Product code HXB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)