ModerateClass IITerminated

FDA Devices recall · Reported September 3, 2014

Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA ENDO FEMORAL HEAD 43MM DIA ENDO FEMORAL HEAD 44MM DIA ENDO FEMORAL HEAD 45MM DIA ENDO FEMORAL HEAD 46MM DIA ENDO FEMORAL HEAD 47MM DIA ENDO FEMORAL HEAD 48MM DIA ENDO FEMORAL HEAD 49MM DIA ENDO FEMORAL HEAD 50MM DIA ENDO FEMORAL HEAD 51MM DIA ENDO FEMORAL HEAD 52MM DIA ENDO FEMORAL HEAD 53MM DIA ENDO FEMORAL HEAD 54MM DIA ENDO FEMORAL HEAD 55MM DIA ENDO FEMORAL HEAD 57MM DIA ENDO FEMORAL HEAD 60

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on September 3, 2014. Severity: Moderate. Recall number: Z-2547-2014.

Q: Where was the recalled product distributed?

Distribution: Worldwide 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.

Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, mu…

Recall #: Z-2547-2014
Affected scope: 972,125 units
Initiated: July 22, 2014

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

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Zimmer, Inc. recalled Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA E… - a moderate-severity action.

Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA E… was recalled by Zimmer, Inc. in September 3, 2014. Reason: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configuration…. Check the official notice for the remedy. Verify recall #Z-2547-2014 with the FDA Devices before acting.

The recall

Zimmer, Inc. issued this moderate-severity FDA Devices recall-Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configuration….

Moderate
severity level: 972K units
affected scope: Class II
classification: September 3, 2014
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2547-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope (see the Recall Profile below) is large enough to require multi-state distribution tracking. 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

Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA ENDO FEMORAL HEAD 43MM DIA ENDO FEMORAL HEAD 44MM DIA ENDO FEMORAL HEAD 45MM DIA ENDO FEMORAL HEAD 46MM DIA ENDO FEMORAL HEAD 47MM DIA ENDO FEMORAL HEAD 48MM DIA ENDO FEMORAL HEAD 49MM DIA ENDO FEMORAL HEAD 50MM DIA ENDO FEMORAL HEAD 51MM DIA ENDO FEMORAL HEAD 52MM DIA ENDO FEMORAL HEAD 53MM DIA ENDO FEMORAL HEAD 54MM DIA ENDO FEMORAL HEAD 55MM DIA ENDO FEMORAL HEAD 57MM DIA ENDO FEMORAL HEAD 60MM DIA ENDO FEMORAL HEAD 63MM DIA ENDO FEM HEAD 41MM ENDO FEM HEAD 42MM ENDO FEM HEAD 43MM ENDO PROS HEAD 44MM ENDO FEM HEAD 45MM ENDO FEM HEAD 46MM ENDO FEM HEAD 47MM ENDO FEM HEAD 48MM ENDO FEM HEAD 49MM ENDO FEM HEAD 50MM ENDO FEM HEAD 51MM ENDO FEM HEAD 52MM ENDO FEM HEAD 53MM ENDO FEM HEAD 54MM ENDO FEM HEAD 55MM ENDO FEM HEAD 57MM ENDO FEM HEAD 60MM ENDO FEM HEAD 63MM UNIPOLAR COMPONENT, 41MM UNIPOLAR COMPONENT, 42MM UNIPOLAR COMPONENT, 43MM UNIPOLAR COMPONENT, 44MM UNIPOLAR COMPONENT, 45MM UNIPOLAR COMPONENT, 46MM UNIPOLAR COMPONENT, 47MM UNIPOLAR COMPONENT, 48MM UNIPOLAR COMPONENT, 49MM UNIPOLAR COMPONENT, 50MM UNIPOLAR COMPONENT, 51MM UNIPOLAR COMPONENT, 52MM UNIPOLAR COMPONENT, 53MM UNIPOLAR COMPONENT, 54MM UNIPOLAR COMPONENT, 55MM UNIPOLAR COMPONENT, 56MM UNIPOLAR COMPONENT, 57MM UNIPOLAR COMPONENT, 58MM UNIPOLAR COMPONENT, 59MM UNIPOLAR COMPONENT, 60MM

Reason for recall

Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.

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-2547-2014
Date reported	September 3, 2014
Date initiated	July 22, 2014
Recalling firm	Zimmer, Inc.
Firm location	Warsaw, IN
Affected scope	972,125 units
Distribution	Worldwide Distribution.

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

Scale of Impact

972,125 units units affected - multi-state distribution scale.

Regional (<10K units) -

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) ✓ This recall

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-2547-2014) 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? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on September 3, 2014. Severity: Moderate. Recall number: Z-2547-2014.

Where was the recalled product distributed? ▼

Distribution: Worldwide 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.

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Similar Medical Devices · nearest report date

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

4001PS Neonatal/Paed.Intubation Kit 2.5mm… 2014-09-03 H4001S Neonatal/Paed.Intubation Kit 2.5mm… 2014-09-03 H4002PS Neonatal/Paed.Intubation Kit 3.0m… 2014-09-03 H4002S Neonatal/Paed.Intubation Kit 3.0mm… 2014-09-03

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This recall: FDA Devices, reported September 3, 2014. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026