Z-2220-2012 Class II Terminated
FDA device recall Z-2220-2012 was initiated by DePuy Orthopaedics, Inc. on Jul 24, 2012 and is designated Class II. Reason for recall: In the recalled lot, the products were not machined according to the production router, a size 52 cup (122136052) was machined instead. This resulted in a size 52 liner being etched and labeled as a… The recall status is terminated (terminated Apr 30, 2013). Affected quantity: 20 liners.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 29, 2012
- Initiation Date
- Jul 24, 2012
- Termination Date
- Apr 30, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 liners
Product Description
Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip joint to help increase patient mobility and to reduce pain. Packaging: Product is placed into a PETG tray, sealed with a Tyvek lid. This is placed into a second PETG tray and sealed with a Tyvek lid. This package is placed into a paperboard carton, labeled, and shrink-wrapped. Intended Use: An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Reason for Recall
In the recalled lot, the products were not machined according to the production router, a size 52 cup (122136052) was machined instead. This resulted in a size 52 liner being etched and labeled as a size 54 liner.
Distribution Pattern
Worldwide Distribution - USA including PA and the country of Canada
Code Information
Catalog number: 1221-36-054 and Lot Number: 231859
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2220-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026