Z-2173-2011

NEXGEN COMPLETE KNEE SOLUTION FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR, NONSTERILE, REF 00-5901-026-00...

Name: Z-2173-2011 NEXGEN COMPLETE KNEE SOLUTION FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR, NONSTERILE, REF 00-5901-026-00...
Creator: Zimmer Inc.
Published: 2011-03-14
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2011-03-14 / Terminated / root cause: design

FDA source

Zimmer Inc. began a recall of NEXGEN COMPLETE KNEE SOLUTION FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR, NONSTERILE, REF 00-5901-026-00, Zimmer UK, Ltd., Zimmer Warsaw, IN. Intended use: The... on 2011-03-14. The reason FDA records is "The firm is initiating a recall due to the potiential for the spring clip to break off during use and fall into the surgical site. The firm has received 24 complaints of the spring breaking, four of which were reported...". 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-2173-2011
Status: Terminated
Initiated: 2011-03-14
Posted: 2011-05-10
Terminated: 2013-08-28
Recalling firm: Zimmer GmbH
Product: NEXGEN COMPLETE KNEE SOLUTION FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR, NONSTERILE, REF 00-5901-026-00, Zimmer UK, Ltd., Zimmer Warsaw, IN. Intended use: 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 firm is initiating a recall due to the potiential for the spring clip to break off during use and fall into the surgical site. The firm has received 24 complaints of the spring breaking, four of which were reported that the patient had to undergo additional x-rays to ensure the fractured clip had not been left in-vivo.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Zimmer, sent an "URGENT MEDICAL DEVICE RECALL" notice dated March 14, 2011 to its Consignees/customers. The letter described the product, problem, and the actions to be taken. The customers were instructed to stop using the device and quarantine immediately; carry out a physical count of all affected product in their territory and record this data on the Inventory Return Certification Form and fax to (574) 372-4265; ensure they have provided acknowledgement via "email return receipt" upon receiving notification; return the recalled product along with the completed Inventory Return Certification Form and Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580-Note: The instrument must be returned even if the spring clip is not missing from the instrument; and if they distributed these affected lots further, provide a copy of this letter to the those customers when they implement these recall instructions. The letter stated that a new or refurbished instrument with a redesigned spring clip will be provided as replacement for the recalled device. For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc. at 1-800-613-6131.
Quantity in commerce: 802 devices
Distribution: Worldwide distribution: USA (nationwide)including states of: HI, CA, NY, MI, IN, GA, FL, WI, MN, NJ, IL, VA, TX, NC, PA, MS, WA, OR, OH, KS, TN, NH, AZ, NV, UT and AK and countries of : Australia, Canada, China, Germany, India, Japan, Singapore and Sweden.
Product codes and lots: 61516146, 61522231, 61542077, 61550613, 61565681, 61584069, 61584438, 61594876, 61610343, 61637191, 61657309, 61659596 61675231, 61691488, 61701224 and 61708918.

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)