Z-1615-2009

Zimmer femoral stem, revision taper, 15 mm diameter, 185 mm stem length, w/compression nut, sterile, Zimmer...

Name: Z-1615-2009 Zimmer femoral stem, revision taper, 15 mm diameter, 185 mm stem length, w/compression nut, sterile, Zimmer...
Creator: Zimmer Inc.
Published: 2009-05-15
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-05-15 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of Zimmer femoral stem, revision taper, 15 mm diameter, 185 mm stem length, w/compression nut, sterile, Zimmer, Warsaw, IN; Model Number: 9982-15-18. Cement-less... on 2009-05-15. The reason FDA records is "The threads on the screw are incomplete/non-functional". 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-1615-2009
Status: Terminated
Initiated: 2009-05-15
Posted: 2009-07-06
Terminated: 2009-11-12
Recalling firm: Zimmer GmbH
Product: Zimmer femoral stem, revision taper, 15 mm diameter, 185 mm stem length, w/compression nut, sterile, Zimmer, Warsaw, IN; Model Number: 9982-15-18. Cement-less total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques. Devices placed in femoral canal. A variety of stem and body components are provided to achieve fixation and restore joint kinematics.
Product code: LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Reason for recall: The threads on the screw are incomplete/non-functional.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Zimmer, Inc. began Consignee notification of the affected device via telephone on May 15, 2009. A certified "Urgent: Device Recall" notification dated May 21, 2009 was sent to all consignees instructing them of the affected device, to stop use of and return it with a Return Certification form. The Return Verification form should also be faxed to Zimmer, Inc. at 1-574-372-4265. For shipping assistance, questions or other concerns, contact Zimmer, Inc. at 1-800-613-6131.
Quantity in commerce: 10
Distribution: Worldwide Distribution -- US states of IA, NE and CA and countries of Canada, Switzerland, United Kingdom, Hungary, Netherlands and Slovakia.
Product codes and lots: Lot Number: 60698102.

Product code LWJ

K992667Class IIZmr Hip System-Revision TaperZimmer, Inc. / cleared 1999-10-27

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)