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Smith & Nephew BIOSURE HA Interference Screw, 7 mm x 25 mm recallZ-1225-2012 · Smith & Nephew, Inc. Endoscopy Division · initiated Feb 6, 2012

Terminated All recalls posted in March 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smith & Nephew, Inc. Endoscopy Division or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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).

FDA root cause category: Packaging process control

What the company is doing

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 [email protected]. 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.

Recall details

Recall number
Z-1225-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 6, 2012
Posted by the FDA
Mar 19, 2012
Recalling firm
Smith & Nephew, Inc. Endoscopy Division
Quantity
194 units
Product code
HWC
FDA submissions
K080358
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, Switzerland, Thailand, and United Kingdom.

Product description

Smith & Nephew BIOSURE HA Interference Screw, 7 mm x 25 mm Catalog Number: 72201772. The BIOSURE HA Interference Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts during anterior/posterior cruciate ligament (ACL/PCL) reconstruction procedures.

Code information (models, lots, serial numbers)

Lot Number: 50397157

Other devices under the same FDA submission

18 devices cleared under K080358 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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