DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing Product Code: 281103 Fluid Tissue

FDA device recall Z-1947-2011 · posted 2011-04-12 · Terminated

Recall details

Recalling firm

DePuy Mitek, Inc., a Johnson & Johnson Co.

Reason for recall

Product sterility may be compromised due to breach in sterile packaging

Action taken

Depuy Mitek sent an Urgent Voluntary Product Recall letter dated December 2, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to isolate all inventory of the affected product and call 1-800-382-4682, PROMPT 3, for return good authorization and replacement product. Customers were instructed to return all identified affected product to: DePuy Mitek ATTN: Recall Coordinator 50 Scotland Boulevard Bridgewater, MA 02324 Record their assigned return material authorization (RMA) number on the outer shipping box. Use the Prepaid Federal Express shipping label for the return of the product. Include a photo copy of the completed business reply form. For questions or concerns call 1-800-382-4682, PROMPT 3.

Root cause

Packaging process control

Status

Terminated

Product code

HBX

Quantity affected

7344 units (372 boxes x 24 pieces)

Distribution

Worldwide Distribution - USA (nationwide) and the coutnries of United Arab Emirates, Australia, Belgium, Switzerland, Czech, Denmark, France, UK, Italy, Netherlands, Poland, and Slovakia.

Date initiated

2010-12-03

Date posted

2011-04-12

Date terminated

2013-04-02

Location

Raynham, MA