Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150… recallZ-1122-2015 · Biomet, Inc. · initiated Jan 9, 2015
Class II Terminated All recalls posted in February 2015
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
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.
FDA root cause category: Packaging process control
What the company is doing
Biomet notified all domestic and foreign customers via FEDEx overnight on 1/9/2015. Response forms were provided, customers were instructed to notify hospital personnel if product was further distributed, and remove recalled products from circulation. Replacement parts were made available, customers may contact Audrey Daenzer, Field Action Specialist, Regulatory Compliance Biomet, Inc., [email protected], or 574-372-1570 Monday- Friday 8 AM to 5 PM.
Recall details
- Recall number
- Z-1122-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 9, 2015
- Posted by the FDA
- Feb 17, 2015
- Recalling firm
- Biomet, Inc.
- Quantity
- 17
- Product code
- LPH
- FDA submissions
- K030055
- Distribution
- Distributed in the states of VA and TX and the country of Japan.
Product description
Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
Code information (models, lots, serial numbers)
Catalog Number: 13-104150 Lot Number Identification: 364600
Other devices under the same FDA submission
40 devices cleared under K030055 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- REACH MODULAR HIP SYSTEM 21-108295Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 recall0 reports
- REACH MODULAR HIP SYSTEM 21-108395Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 recall0 reports
- BI-METRIC X-SERIES HIP SYSTEM X21-180307Biomet Orthopedics, LLC · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall0 reports
- BI-METRIC X-SERIES HIP SYSTEM X21-180308Biomet Orthopedics, LLC · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall0 reports
- BI-METRIC X-SERIES HIP SYSTEM X21-180309Biomet Orthopedics, LLC · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall0 reports
- BI-METRIC X-SERIES HIP SYSTEM X21-180310Biomet Orthopedics, LLC · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall0 reports
- BI-METRIC X-SERIES HIP SYSTEM X21-180311Biomet Orthopedics, LLC · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall0 reports
- BI-METRIC X-SERIES HIP SYSTEM X21-180312Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 recall0 reports
- BI-METRIC X-SERIES HIP SYSTEM X21-180313Biomet Orthopedics, LLC · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall0 reports
- BI-METRIC X-SERIES HIP SYSTEM X21-180314Biomet Orthopedics, LLC · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall0 reports
- BI-METRIC X-SERIES HIP SYSTEM X21-180315Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 recall0 reports
- BI-METRIC X-SERIES HIP SYSTEM X21-180316Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 70438).
- Z-1123-2015 · TerminatedRingloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.
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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