Severity
Moderate
Zimmer, Inc. issued this FDA Devices recall on September 3, 2014. Classified as Moderate severity (Class II). Approximately 972,125 units units are affected. The recall was issued because: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to p…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
This FDA Devices action (record #Z-2551-2014) was formally reported on September 3, 2014, with the manufacturer initiating the action on July 22, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Zimmer, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records indicate 972,125 units units are affected, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: 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 si… Distribution data in the federal record shows the product reached: Worldwide Distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Severity
Moderate
Units Affected
972,125 units
Related Recalls
6
6 from same agency
Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP 41HDX127ST FNSTRD HIP 42HDX127ST FNSTRD HIP 43HDX127ST FNSTRD HIP 44HDX127ST FNSTRD HIP 45HDX140ST FNSTRD HIP 46HDX140ST FNSTRD HIP 47HDX140ST FNSTRD HIP 48HDX140ST FNSTRD HIP 49HDX140ST FNSTRD HIP 50HDX152ST FNSTRD HIP 51HDX152ST FNSTRD HIP 52HDX152ST FNSTRD HIP 53HDX152ST FNSTRD HIP 54HDX152ST FNSTRD HIP 55HDX152ST FNSTRD HIP 57HDX152ST FNSTRD HIP 60HDX152ST FNSTRD HIP 63HDX152ST FNSTRD HIP 38HDX140ST FNSTRD HIP 40HDX140ST FNSTRD HIP 41HDX140ST FNSTRD HIP 42HDX140ST FNSTRD HIP 43HDX140ST FNSTRD HIP 44HDX140ST FNSTRD HIP 45HDX152ST FNSTRD HIP 46HDX152ST FNSTRD HIP 47HDX152ST FNSTRD HIP 48HDX152ST FNSTRD HIP 49HDX152ST FNSTRD HIP 50HDX152ST FNSTRD HIP 51HDX152ST HIP PROS 38HDX105ST HIP PROS 40HDX105ST HIP PROS 41HDX105ST HIP PROS 42HDX105ST HIP PROS 43HDX105ST HIP PROS 44HDX105ST HIP PROS 45HDX105ST HIP PROS 46HDX105ST HIP PROS 47HDX105ST HIP PROS 48HDX105ST HIP PROS 49HDX105ST HIP PROS 50HDX105ST HIP PROS 51HDX105ST HIP PROS 52HDX105ST HIP PROS 53HDX105ST HIP PROS 54HDX105ST HIP PROS 55HDX105ST HIP PROS 57HDX105ST HIP PROS 60HDX105ST HIP PROS 63HDX105ST FNSTRD HIP 38HDX165ST FNSTRD HIP 40DX165ST FNSTRD HIP 41HDX165ST FNSTRD HIP 42HDX165ST FNSTRD HIP 43HDX165ST FNSTRD HIP 44HDX165ST FNSTRD HIP 45HDX165ST FNSTRD HIP 46HDX165ST FNSTRD HIP 47HDX165ST FNSTRD HIP 48HDX165ST FNSTRD HIP 49HDX165ST FNSTRD HIP 50HDX191ST FNSTRD HIP 51HDX191ST FNSTRD HIP 52HDX191ST FNSTRD HIP 53HDX191ST FNSTRD HIP 54HDX191ST FNSTRD HIP 55HDX191ST FNSTRD HIP 57HDX191ST FNSTRD HIP 60HDX191ST FNSTRD HIP 63HDX191ST FNSTRD HIP 38HDX165ST FNSTRD HIP 41HDX165ST FNSTRD HIP 43HDX165ST FNSTRD HIP 44HDX165ST FNSTRD HIP 46HDX165ST FNSTRD HIP 48HDX165ST FNSTRD HIP 49HDX165ST FNSTRD HIP 51HDX165ST HIP PROS 38HDX127ST HIP PROS 40HDX127ST HIP PROS 41HDX127ST HIP PROS 42HDX127ST HIP PROS 43HDX127ST HIP PROS 44HDX127ST HIP PROS 45HDX140ST HIP PROS 46HDX140ST HIP PROS 47HDX140ST HIP PROS 48HDX140ST HIP PROS 49HDX140ST HIP PROS 50HDX152ST HIP PROS 51HDX152ST HIP PROS 52HDX152ST HIP PROS 53HDX152ST HIP PROS 54HDX152ST HIP PROS 55HDX152ST HIP PROS 57HDX152ST HIP PROS 60HDX152ST HIP PROS 63HDX152ST HIP PROS 38HDX165ST HIP PROS 40HDX165ST HIP PROS 41HDX165ST HIP PROS 42HDX165ST HIP PROS 43HDX165ST HIP PROS 44HDX165ST HIP PROS 45HDX165ST HIP PROS 46HDX165ST HIP PROS 47HDX165ST HIP PROS 48HDX165ST HIP PROS 49HDX165ST HIP PROS 50HDX191ST HIP PROS 51HDX191ST HIP PROS 52HDX191ST HIP PROS 53HDX191ST HIP PROS 54HDX191ST HIP PROS 55HDX191ST HIP PROS 57HDX191ST HIP PROS 60HDX191ST HIP PROS 63HDX191ST
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2551-2014 |
| Date reported | September 3, 2014 |
| Date initiated | July 22, 2014 |
| Recalling firm | Zimmer, Inc. |
| Units affected | 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.
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Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
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Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).