Z-0495-2011

Zimmer Reconstruction System Tenaculum Straight Tine Straight 9 inch, Item # 00-1179-023-00, Zimmer Inc...

Name: Z-0495-2011 Zimmer Reconstruction System Tenaculum Straight Tine Straight 9 inch, Item # 00-1179-023-00, Zimmer Inc...
Creator: Zimmer Inc.
Published: 2010-02-16
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2010-02-16 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of Zimmer Reconstruction System Tenaculum Straight Tine Straight 9 inch, Item # 00-1179-023-00, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic... on 2010-02-16. The reason FDA records is "The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0495-2011
Status: Terminated
Initiated: 2010-02-16
Posted: 2010-12-01
Terminated: 2011-10-05
Recalling firm: Zimmer GmbH
Product: Zimmer Reconstruction System Tenaculum Straight Tine Straight 9 inch, Item # 00-1179-023-00, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
Product code: HWN Instrument, Compression
Reason for recall: The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Zimmer sent an Urgent Device Recall letter dated February 16, 2010, to all affected customers. The letter identified the product, the problem, and the action the customers should take. Customers were instructed to monitor all potentially affected patients through regular office consultations. Ensure Zimmer Reconstruction System Tenaculum System Instrument Users at their facility were informed of the urgent device recall. Locate all instruments and quarantine them immediately. Count all affected product in their territory and record the data on the Inventory Return Certification Form included with the letter. Fax a copy of the completed Inventory Return Form to: Zimmer, Inc. at (574) 372-4265. Return the recalled product along with the original completed Inventory Return Certification Form to: Zimmer Distribution Center Attn: Product Service 1777 West Center Street Warsaw, IN 46580 For questions customers were instructed to contact their Zimmer Sales Representative. For questions regarding this recall call 1 - (800) 613-6131.
Distribution: Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
Product codes and lots: lot #'s: 60806992 and 60921166

Product code HWN

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)