Z-0198-2010

Zimmer VerSys Hip System Femoral Head, 12/14 taper, 28 mm dia., neck length +0 mm, sterile, Zimmer, Warsaw...

Name: Z-0198-2010 Zimmer VerSys Hip System Femoral Head, 12/14 taper, 28 mm dia., neck length +0 mm, sterile, Zimmer, Warsaw...
Creator: Zimmer Inc.
Published: 2009-08-03
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-08-03 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of Zimmer VerSys Hip System Femoral Head, 12/14 taper, 28 mm dia., neck length +0 mm, sterile, Zimmer, Warsaw, IN; REF 8018-28-02. Intended for mating femoral... on 2009-08-03. The reason FDA records is "Manufacturing material may be present on the surface of the implant". 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-0198-2010
Status: Terminated
Initiated: 2009-08-03
Posted: 2009-11-13
Terminated: 2009-12-15
Recalling firm: Zimmer GmbH
Product: Zimmer VerSys Hip System Femoral Head, 12/14 taper, 28 mm dia., neck length +0 mm, sterile, Zimmer, Warsaw, IN; REF 8018-28-02. Intended for mating femoral stems equipped with tapered necks.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Manufacturing material may be present on the surface of the implant.
Root cause tag: manufacturing process
FDA root cause: Manufacturing material removal
Action: An Urgent: Device Recall letter, dated 8/3/2009, was issued to consignees. The letter identified the affected product, stated the reason for the recall, the clinical implications (risks to health), and actions to be taken. Customers are to locate any unused devices and quarantine them immediately, carry out a physical count of affected product and record the data on the Return Certification Form included with the letter, and fax a copy of the completed form back to Zimmer, Inc. at 574-372-4265. Customers are to return the recalled product along with the completed Inventory Return Certification Form. A "Dear Surgeon" letter will be issued to any hospitals where the devices have been implanted.
Quantity in commerce: 104
Distribution: Worldwide Distribution -- USA, Brazil, Canada, and Switzerland.
Product codes and lots: Lot 60378581.

Product code LPH

K953337Class IIBeta Hip ProsthesisZimmer, Inc. / cleared 1996-01-22

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)