FDA Medical Device Recalls (openFDA)
DePuy Mitek, Inc., a Johnson & Johnson Co.: DePuy Mitek FMS Irrigation Intermediary Tube With One-way Valve Arthroscopy tubing Product Code: 281142 Fluid Tissue Management
- Recall number
- Z-1946-2011
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Product
- DePuy Mitek FMS Irrigation Intermediary Tube With One-way Valve Arthroscopy tubing Product Code: 281142 Fluid Tissue Management
- Status
- Terminated
- Initiated
- 2010-12-03
- Posted
- 2011-04-12
- Terminated
- 2013-04-02
- Reason
- Product sterility may be compromised due to breach in sterile packaging
- 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
- 50,376 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the coutnries of United Arab Emirates, Australia, Belgium, Switzerland, Czech, Denmark, France, UK, Italy, Netherlands, Poland, and Slovakia.
- Lot, serial or model codes
- Lot Codes: 1060792 1060824 1060841 1060851 BBBA0953D BBBA0953E BBBA0953F BBBA0953G BBBA1001T BBBA1001V BBBA1002H BBBA1002I BBBA1005D BBBA1005E BBBA1005F BBBA1005G BBBA1007J BBBA1008C BBBA1008E BBBA1010G BBBA1010H BBBA1010J BBBA1010K BBBA1012B BBBA1012C BBBA1012E BBBA1014A BBBA1014E BBBA1015F BBBA1015G BBBA1018E BBBA1018F BBBA1020B BBBA1020C
- 510(k) numbers
- ["K951843"]
- PMA numbers
- not on file
- Product code
- HBX
- Firm FEI
- 1221934
- Firm city
- Raynham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28