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Recall Observatory FDA recall evidence

Device 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.

Z-1366-2013

March 07, 2012

Class II

Product summary

Firm
DePuy Orthopaedics, Inc.
Event
Event 61315
Status
Terminated
Classification
Class II
Quantity
20 liners
Official record key
device-enforcement:Z-1366-2013

Official wording

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.

Code information: product code1221-36-452, lot 187460.

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrectly labeled