19 mm Mallory Head Calcar 55 mm repl. femoral/100% porous… recallZ-1679-2010 · Biomet, Inc. · initiated Mar 10, 2010
Terminated All recalls posted in May 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Process change control
What the company is doing
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.
Recall details
- Recall number
- Z-1679-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 10, 2010
- Posted by the FDA
- May 26, 2010
- Recalling firm
- Biomet, Inc.
- Quantity
- 6
- Product code
- LPH
- FDA submissions
- K031693
- Distribution
- Worldwide Distribution -- United States (OH, IN, FL, KY, NV and CA), Mexico, Chile, China, Japan and The Netherlands.
Product description
19 mm Mallory Head Calcar 55 mm repl. femoral/100% porous 20.5 mm minimum ream dia. x 260 mm lt.., Sterile, REF CP154604, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in femoral revision surgery.
Code information (models, lots, serial numbers)
Lot Number: M920160.
Other devices under the same FDA submission
2 devices cleared under K031693 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MALLORY/HEAD CALCAR HIP SYSTEM 11-104955Biomet Orthopedics, LLC · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- MALLORY/HEAD CALCAR HIP SYSTEM 11-104973Biomet Orthopedics, LLC · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 55365).
- Z-1665-2010 · TerminatedMallory Head Calcar Provisional, 34 mm replacement stem, 11 mm x 220 mm left, Sterile, REF 104773, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in femor…
- Z-1666-2010 · TerminatedMallory Head Calcar Provisional, 45 mm replacement stem, 13.0 x 220 mm left, Sterile, REF 104986, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in femoral…
- Z-1667-2010 · TerminatedMallory Head Calcar Femoral, 34 mm resection/porous coated, 9mm x 170 mm stem, Sterile, REF 11-104902, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in fe…
- Z-1668-2010 · TerminatedMallory Head Calcar Femoral, 34 mm resection/porous coated, 13.0 x 170 mm,, Sterile, REF 11-104904, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in femor…
- Z-1669-2010 · TerminatedMallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 170 mm stem, Sterile, REF 11-104905, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use i…
- Z-1670-2010 · TerminatedMallory Head Calcar Provisional, 55 mm resection/porous coated, 17.0 mm x 260 mm left, Sterile, REF 11-104939, Biomet Orthopaedics, Warsaw, IN. Implant device intended for u…
- Z-1671-2010 · TerminatedMallory Head Calcar Femoral, 34 mm resection/porous coated, 9.0 mm x 220 mm right stem, Sterile, REF 11-104947, Biomet Orthopaedics, Warsaw, IN. Implant device intended for …
- Z-1672-2010 · TerminatedMallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 220 mm right stem, Sterile, REF 11-104953, Biomet Orthopaedics, Warsaw, IN. Implant device intended for…
- Z-1673-2010 · TerminatedMallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 220 mm left stem, Sterile, REF 11-104954, Biomet Orthopaedics, Warsaw, IN. Implant device intended for …
- Z-1674-2010 · TerminatedMallory Head Calcar Femoral, 55 mm resection/porous coated, 15.0 mm x 220 mm right stem, Sterile, REF 11-104971, Biomet Orthopaedics, Warsaw, IN. Implant device intended fo…
- Z-1675-2010 · TerminatedMallory Head Calcar Femoral 55 mm resection/porous coated 15.0 mm x 220 mm left stem, Sterile, REF 11-104972, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use …
- Z-1676-2010 · Terminated17 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…
- Z-1677-2010 · Terminated17 mm Mallory Head Calcar 55 mm repl. femoral/100% porous 18.5 mm minimum ream dia. x 220 mm rt., Sterile, REF CP154593, Biomet Orthopaedics, Warsaw, IN. Implant device inten…
- Z-1678-2010 · Terminated19 mm Mallory Head Calcar 45 mm repl. femoral/100% porous 20.5 mm minimum ream dia. x 260 mm rt., Sterile, REF CP154599, Biomet Orthopaedics, Warsaw, IN. Implant device inten…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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