Z-1366-2013 Class II Terminated
FDA device recall Z-1366-2013 was initiated by DePuy Orthopaedics, Inc. on Mar 7, 2012 and is designated Class II. Reason for recall: DePuy Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of one lot of the AltrX" liner because the product was incorrectly labeled on the box. The box was labeled for a 36IDX52OD +4 Neutral… The recall status is terminated (terminated May 24, 2013). Affected quantity: 20 liners.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2013
- Initiation Date
- Mar 7, 2012
- Termination Date
- May 24, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 liners
Product Description
Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: 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
DePuy Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of one lot of the AltrX" liner because the product was incorrectly labeled on the box. The box was labeled for a 36IDX52OD +4 Neutral Liner, but the product enclosed was a 36IDX56OD Neutral Liner. Three ( 3 ) complaints were received in January 2012.
Distribution Pattern
Worldwide Distribution - USA Nationwide including the state of VA and the country of Ireland.
Code Information
product code1221-36-452, lot 187460.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1366-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026