Recall Z-1366-2013— DePuy Orthopaedics, Inc.

Name: FDA recall Z-1366-2013
Creator: U.S. Food and Drug Administration
Published: 2012-03-07

Class II · Terminated

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2012-03-07, terminated 2013-05-24. It names one FDA 510(k) clearance: K102423. 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.. Reason: 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..

Recalling firm: DePuy Orthopaedics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-03-07
Terminated: 2013-05-24
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K102423 — DEPUY PINNACLE ALTRX ACETABULAR LINERSDePuy Orthopaedics, Inc.·cleared 2010-10-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.