ModerateClass IITerminated

FDA Devices recall · Reported July 18, 2012

Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu, Cedex France. Made in Ireland. The Definition PM femoral hip stem is a forged, collared, straight stem with an integral premantle (PM) design. The Poly Methyl Methacrylate (PMMA) and Barium Sulphate (BaSO4) premantle is

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on July 18, 2012. Severity: Moderate. Recall number: Z-1982-2012.

Q: Where was the recalled product distributed?

Distribution: Nationwide Distribution.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product.

Recall #: Z-1982-2012
Affected scope: 16,913 units
Initiated: December 29, 2011

Compiled from official public sources by the publisher. · Updated September 2026

Verify with FDA Devices →

View my saved recalls

Stryker Howmedica Osteonics Corp. recalled Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6… - a moderate-severity action.

Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6… was recalled by Stryker Howmedica Osteonics Corp. in July 18, 2012. Reason: Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip …. Check the official notice for the remedy. Verify recall #Z-1982-2012 with the FDA Devices before acting.

The recall

Stryker Howmedica Osteonics Corp. issued this moderate-severity FDA Devices recall-Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip ….

Moderate
severity level: 17K units
affected scope: Class II
classification: July 18, 2012
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1982-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu, Cedex France. Made in Ireland. The Definition PM femoral hip stem is a forged, collared, straight stem with an integral premantle (PM) design. The Poly Methyl Methacrylate (PMMA) and Barium Sulphate (BaSO4) premantle is integral to the design as it aligns, centralizes and pressurizes the stem within the femoral canal. The forged stem is first grit blasted proximally and then the premantle is applied through an infection molding process.

Reason for recall

Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1982-2012
Date reported	July 18, 2012
Date initiated	December 29, 2011
Recalling firm	Stryker Howmedica Osteonics Corp.
Firm location	Mahwah, NJ
Affected scope	16,913 units
Distribution	Nationwide Distribution

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

16,913 units units affected - limited or regional distribution scale.

Regional (<10K units) -

Multi-state (10K – 100K units) ✓ This recall

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1982-2012) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on July 18, 2012. Severity: Moderate. Recall number: Z-1982-2012.

Where was the recalled product distributed? ▼

Distribution: Nationwide Distribution.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

Trampolines Recalled by Panline USA Due t… 2012-07-18 Samuel Lawrence Furniture Expands Recall … 2012-07-18 TRUMPF Medical Systems Recalls Television… 2012-07-18 Trizivir (abacavir sulfate 300mg, lamivud… 2012-07-18

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Alere Triage CardioProfiler Panel PN 9710… 2012-07-18 Alere Triage Cardiac Panel PN 97000HS … 2012-07-18 Alere Triage Profiler SOB Panel PN 97300 … 2012-07-18 Alere Triage BNP PN 98000XR Intended t… 2012-07-18

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported July 18, 2012. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026