Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: An acetabular liner is used i

FDA device recall Z-1366-2013 · posted 2013-05-22 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

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.

Action taken

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.

Root cause

Packaging process control

Status

Terminated

Product code

LPH

Quantity affected

20 liners

Distribution

Worldwide Distribution - USA Nationwide including the state of VA and the country of Ireland.

Date initiated

2012-03-07

Date posted

2013-05-22

Date terminated

2013-05-24

Location

Warsaw, IN

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