Z-1676-2010

17 mm Mallory Head Calcar 45 mm repl. fmrl. /100% porous 18.5 mm minimum ream dia x 260 mm rt., Sterile, REF...

Name: Z-1676-2010 17 mm Mallory Head Calcar 45 mm repl. fmrl. /100% porous 18.5 mm minimum ream dia x 260 mm rt., Sterile, REF...
Creator: Biomet, Inc.
Published: 2010-03-10
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2010-03-10 / Terminated

FDA source

Biomet, Inc. began a recall of 17 mm Mallory Head Calcar 45 mm repl. fmrl. /100% porous 18.5 mm minimum ream dia x 260 mm rt., Sterile, REF CP154591, Biomet Orthopaedics, Warsaw, IN. Implant... on 2010-03-10. The reason FDA records is "The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1676-2010
Status: Terminated
Initiated: 2010-03-10
Posted: 2010-05-26
Terminated: 2010-10-18
Recalling firm: Zimmer GmbH
Product: 17 mm Mallory Head Calcar 45 mm repl. fmrl. /100% porous 18.5 mm minimum ream dia x 260 mm rt., Sterile, REF CP154591, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in femoral revision surgery.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep.
FDA root cause: Process change control
Action: Biomet Orthopedics issued an "Urgent Medical Device Recall Notice" dated March 10, 2010. The letter went to distributors and users of the recalled device. The letter instructed the consignees to locate the recalled product and return the product to the firm. For further information, contact Biomet at 1-800-348-9500 or 1-574-372-3983, Monday through Friday, 8:00 AM to 5:00 PM.
Quantity in commerce: 11
Distribution: Worldwide Distribution -- United States (OH, IN, FL, KY, NV and CA), Mexico, Chile, China, Japan and The Netherlands.
Product codes and lots: Lot Numbers: M609130 and M083500.

Product code LPH

K031693Class IIMallory/head Modular Calcar with and without HaBiomet, Inc. / cleared 2003-08-06

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)