Z-1366-2013Class II

Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452

Name: Z-1366-2013 Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452
Creator: DePuy Orthopaedics, Inc.
Published: 2012-03-07
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2012-03-07 / Terminated / root cause: packaging

FDA source

DePuy Orthopaedics, Inc. began a recall of Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: An acetabular liner is used in combination with other implants for... on 2012-03-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1366-2013
Classification: Class II
Status: Terminated
Initiated: 2012-03-07
Posted: 2013-05-22
Terminated: 2013-05-24
Recalling firm: Depuy Orthopaedics Inc.
Product: 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.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: DePuy Orthopaedics sent an URGENT INFORMATION- MEDICAL DEVICE RECALL NOTICE dated March 7, 2012 via email to all affected distributors and customers. The letter identified the affected product, problem and actions to be taken. Distributors and customers are instructed to cease further distribution or use or of recalled product and to return them to DePuy. The sales representatives are expected to aid customer in returning of recalled product. Distributors and sales representatives are to return the recalled product through the normal DePuy Returns process. Reconciliation form should be completed and returned to your DePuy Sales Representative or faxed to 574-372-7567. For questions about recall information contact the Manager of Customer Quality 574-372-7333.
Quantity in commerce: 20 liners
Distribution: Worldwide Distribution - USA Nationwide including the state of VA and the country of Ireland.
Product codes and lots: product code1221-36-452, lot 187460.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1366-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1366-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-22

Product code LPH

K102423Class IIDepuy Pinnacle Altrx Acetabular LinersDePuy Orthopaedics, Inc. / cleared 2010-10-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)