Severity
Moderate
FDA Devices recall · Reported February 25, 2015
Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging …
Biomet, Inc. recalled Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component. - a moderate-severity action.
Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component. was recalled by Biomet, Inc. in February 25, 2015. Reason: Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell L…. Check the official notice for the remedy. Verify recall #Z-1123-2015 with the FDA Devices before acting.
The recall
Biomet, Inc. issued this moderate-severity FDA Devices recall-Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell L….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1123-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1123-2015) was formally reported on February 25, 2015, with the manufacturer initiating the action on January 9, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Biomet, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records list the affected scope as 17.
The documented reason for this recall is: Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two. Distribution data in the federal record shows the product reached: Distributed in the states of VA and TX and the country of Japan.. Distribution scope 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, 3 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 recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Severity
Moderate
Affected scope
17
Related Recalls
6
3 from same agency
Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.
Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1123-2015 |
| Date reported | February 25, 2015 |
| Date initiated | January 9, 2015 |
| Recalling firm | Biomet, Inc. |
| Firm location | Warsaw, IN |
| Affected scope | 17 |
| Distribution | Distributed in the states of VA and TX and the country of Japan. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
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.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 25, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.