GMRS Extension Piece, 60 mm; Sterile Stryker Howmedica Osteonics; Howmedica Internation S. de. R.L. Limerick, Ireland. T

FDA device recall Z-2624-2010 · posted 2010-09-29 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

Mislabeled package: Package labeled as GMRS Extension Piece 60 mm, lot ZYCOC1 actually contains a GMRS Extension Piece 70 mm extension piece.

Action taken

Stryker issued Important Market WIthdrawal letters dated May 5, 2005 to customers and distributors. The letters identified the affected product, the labeling issue, and actions to be taken by the customer or distributor. Customers were instructed to identify and quarantine affected product, which will be reconciled and returned by the Stryker sales representative. Distributors were instructed to identify affected product, reconcile all product on an attached Product Accountability Form to be faxed to Stryker at 201 831-4825 within two days of receipt of the letter. The affected product was to be returned using the enclosed pre-paid mailing label. Contact the Stryker sales representative to re-order product that is being returned. Stryker can be contacted at 201 831-5825.

Root cause

Labeling mix-ups

Status

Terminated

Product code

KRO

Quantity affected

5 units

Distribution

Nationwide Distribution: USA, including the states of AZ, FL, MD, and PA.G

Date initiated

2005-05-05

Date posted

2010-09-29

Date terminated

2010-10-01

Location

Mahwah, NJ

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