Z-2091-2012Class II

Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile...

Name: Z-2091-2012 Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile...
Creator: Zimmer Inc.
Published: 2012-04-30
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-04-30 / Terminated / root cause: design

FDA source

Zimmer Inc. began a recall of Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached... on 2012-04-30. FDA classified it as Class II and gives the reason as "The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the updated design. The spring clip may...". 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-2091-2012
Classification: Class II
Status: Terminated
Initiated: 2012-04-30
Posted: 2012-07-27
Terminated: 2014-06-04
Recalling firm: Zimmer GmbH
Product: Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the updated design. The spring clip may fracture or fall off of the instrument during use, and a device fragment may be left in the surgical site. The risk of disassembly or fracture occurs when the instrument is typicall
Root cause tag: design
FDA root cause: Component design/selection
Action: Zimmer sent an Urgent Medical Device Recall letter dated April 30, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Requests for alternative instruments should be requested by calling (574) 372-4470. Fax Back Inventory Return Certification Form is to be sent back to Zimmer at (574) 372-4265. All recalled instruments available at the distributor are to be returned to Zimmer Product Service Department, 1777 West Center Street, Warsaw, IN 46580. The Distributor notice included instructions to notify surgeons immediately of the recall and requested a list of hospitals and surgeons receiving the device be sent back to Zimmer via E-mail. Zimmer is continuing distribution of the replacement jaw ( 005901-026-40) until alternative tools are available. The distributors are asked to identify and deliver preferred alternative instruments to affected accounts. Beginning May 7, 2012 Urgent Recall notices are being sent to hospitals and surgeons identified with instructions to acknowledge the recall communication. For questions regarding this recall call 574-372-4807.
Quantity in commerce: 1662 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Singapore, China, Hong Kong, Canada, Australia, Japan, Europe, Germany, India, and Finland.
Product codes and lots: Part 00-5901-026-00 Lot 11002148, 11002149, 11002791, 11002792, 11002831, 11003439, 11003449, 61800676, 61814993, 61909414, 61924920, 61980656, 61985378, 61988272, 61990656, 62003795, 62011220, 77000065, 77000573, 77000574, 77000575, 77000583, 77000654, 77000786, 77000787, 77000788, 77000789, 77000790, 77000795, 77000797, 77000798, 77000799, 77000804, 77000848, 77000849, 77000872, 77000873, 77001039, 77001048, 77001096, 77001097, 77001118, and 77001119

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2091-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2091-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-07-27
Z-2092-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-07-27

Product code MBH

K031061Class IINexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc. / cleared 2003-10-09

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)