Total Hip Joint Replacement Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #3 Accolade TMZF Plus 127 Neck Angle V40 Hip

FDA device recall Z-0075-2012 · posted 2011-10-20 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

Stryker Orthopaedics has become aware that a size 3 Accolade stem was in a box labeled as a size 5 Accolade stem.

Action taken

Stryker Orthopaedics sent an "URGENT: PRODUCT RECALL" letter dated July 14, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and return an attached Product Recall Acknowledgment Form via fax to 201-831-6069. Additionally, information is provided for customers to return the affected products. Please contact the Divisional Regulatory Compliance Manager at 201-972-2100 for questions regarding this notice.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

MEH

Quantity affected

21 units

Distribution

Nationwide Distribution

Date initiated

2011-07-14

Date posted

2011-10-20

Date terminated

2013-11-15

Location

Mahwah, NJ

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