Z-1947-2011

DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing

Name: Z-1947-2011 DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2010-12-03
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2010-12-03 / Terminated / root cause: packaging

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing Product Code: 281103 Fluid Tissue Management on 2010-12-03. The reason FDA records is "Product sterility may be compromised due to breach in sterile packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1947-2011
Status: Terminated
Initiated: 2010-12-03
Posted: 2011-04-12
Terminated: 2013-04-02
Recalling firm: DePuy Mitek, Inc.
Product: DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing Product Code: 281103 Fluid Tissue Management
Product code: HBX Instrument, Cranioplasty Material Forming
Reason for recall: Product sterility may be compromised due to breach in sterile packaging
Root cause tag: packaging
FDA root cause: Packaging process control
Action: 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.
Quantity in commerce: 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.
Product codes and lots: Lot Codes: 1060790 BBBA1001N BBBA1005C BBBA1006G BBBA1014C

Product code HBX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)