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Canadian Recall

On May 28, 2012, Health Canada announced that Stryker Rejuvenate was being recalled so the instructions for use could be updated. The recall affected only Rejuvenate devices sold in Canada and was based on a reported rate of less than one percent for revisions associated with the Rejuvenate.

The Stryker U.S. Stryker voluntary recall does not specify model numbers, but the following information and model numbers were identified in the Health Canada recall notification:

Trade Name

A) Rejuvenate Modular Neck, 0 DEG
B) Rejuvenate Modular Neck, 8 DEG
C) Rejuvenate Modular Neck, 16 DEG
D) Rejuvenate SPT Modular Stem, Straight Press-Fit Texture TMFZ

Recall Posting Date
2012-05-28

Manufacturer
Howmedica Osteonics Corporation

Recall Start Date
2012-04-30

Recall Number
73679

Hazard Classification
Type II

Model or Catalog #
A) NLS-300000B, NLS-340000B, NLS-380000B, NLS-420000B
B) NLV-300800G, NLV-300800Y, NLV-340800G, NLV-340800Y, NLV-380800G, NLV-380800Y, NLV-420800G, NLV-420800Y
C) NLS-301600P, NLS-341600P, NLS-3816000P, NLS-4216000P
D) SPT-070000S, SPT-080000S, SPT-090000S, SPT-100000S, SPT-110000S, SPT-120000S

Lot or Serial #
A) All lots
B) All lots
C) All lots
D) All lots

Reason for Recall
Stryker Orthopedics has updated the instructions for use (IFU) for the Rejuvenate Modular Hip System. This is based on a reported rate of less than one percent for revisions potentially associated with fretting and/or corrosion at or about the modular neck junction.