Z-0597-06

Zimmer Natural Hip System Collarless Stem, porous, with HA coating for cementless use only, sterile, Size 3...

Name: Z-0597-06 Zimmer Natural Hip System Collarless Stem, porous, with HA coating for cementless use only, sterile, Size 3...
Creator: Zimmer Inc.
Published: 2006-02-22
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2006-02-22 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Inc. began a recall of Zimmer Natural Hip System Collarless Stem, porous, with HA coating for cementless use only, sterile, Size 3, Right; Ref 7356-02-103 on 2006-02-22. The reason FDA records is "Misbranded-The package actually contains an APR hip system, HA porous stem, 12 mm, left". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0597-06
Status: Terminated
Initiated: 2006-02-22
Posted: 2006-03-07
Terminated: 2006-04-05
Recalling firm: Zimmer GmbH
Product: Zimmer Natural Hip System Collarless Stem, porous, with HA coating for cementless use only, sterile, Size 3, Right; Ref 7356-02-103.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Misbranded-The package actually contains an APR hip system, HA porous stem, 12 mm, left.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Firm''s sales representatives were notified via email on 2/22/06 to visit the customers, remove the product from inventory, and to return it to the firm.
Quantity in commerce: 5
Distribution: Arizona, Wisconsin and Australia.
Product codes and lots: Lot 1648124.

Product code LPH

K920955Class IIApr(r) Hip Syst & Natural-Hip(r) for Uncement UseIntermedics Orthopedics / cleared 1994-02-09

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)