Z-1122-2015 Class II Terminated
FDA device recall Z-1122-2015 was initiated by Biomet, Inc. on Jan 9, 2015 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Oct 22, 2015). Affected quantity: 17.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 25, 2015
- Initiation Date
- Jan 9, 2015
- Termination Date
- Oct 22, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17
Product Description
Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
Reason for Recall
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 Pattern
Distributed in the states of VA and TX and the country of Japan.
Code Information
Catalog Number: 13-104150 Lot Number Identification: 364600
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1122-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026