Smith & Nephew BIOSURE HA Interference Screw, 7 mm x 25 mm Catalog Number: 72201772. The BIOSURE HA Interference Screw i

FDA device recall Z-1225-2012 · posted 2012-03-19 · Terminated

Recall details

Recalling firm

Smith & Nephew, Inc. Endoscopy Division

Reason for recall

Mislabeled: The device was labeled as a standard thread screw (P/N 72201772) on pouch and box, however the device contained in the packaging is a reverse thread screw (P/N 72201773).

Action taken

Smith & Nephew Endoscopy sent an "URGENT-PRODUCT RECALL 1st NOTIFICATION" dated February 2012 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The letter instructs customers to inspect their inventory and quarantine any affected product. For instructions on returning product, contact the Smith & Nephew Endoscopy Division Returns Group at 800-343-5717 ( 0ption 3) or email to endo.andreturns@smith-nephew.com. Additionally, customers were asked to complete the bottom portion of the letter and to fax it to 1-508-261-3620. Contact the Smith & Nephew Endoscopy Division for questions regarding this notice at 1-508-261-3731.

Root cause

Packaging process control

Status

Terminated

Product code

HWC

Quantity affected

194 units

Distribution

Worldwide Distribution-USA (nationwide) and the states of AK, AZ, CA, CO, CT, IA , MD, MI, MN, MO, MS, NE, OH, OK, PA, SC, and VA and the countries of Australia, Canada, Germany, South Korea, Spain, S

Date initiated

2012-02-06

Date posted

2012-03-19

Date terminated

2016-02-29

Location

Andover, MA

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