DePuy Mitek FMS Irrigation Intermediary Tube Without… recallZ-1948-2011 · DePuy Mitek, Inc., a Johnson & Johnson Co. · initiated Dec 3, 2010
Terminated All recalls posted in April 2011
Is my device affected?
- 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.
- If yours is listed, follow the instructions from DePuy Mitek, Inc., a Johnson & Johnson Co. or your healthcare provider. The company's action is summarized under what the company is doing.
- 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
Product sterility may be compromised due to breach in sterile packaging
FDA root cause category: Packaging process control
What the company is doing
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.
Recall details
- Recall number
- Z-1948-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 3, 2010
- Posted by the FDA
- Apr 12, 2011
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Quantity
- 92,000 units (920 boxes/100)
- Product code
- HBX
- FDA submissions
- K951843
- 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 description
DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing (100 units/box) (International Distribution Only) Product Code: 281102 Fluid Tissue Management
Code information (models, lots, serial numbers)
Lot Codes: 1060789 1060823 1060838 1060848 1061291 1061292 BBBA1001I BBBA1003D BBBA1003E BBBA1004A BBBA1006F BBBA1007D BBBA1008A BBBA1010A BBBA1011D BBBA1014B BBBA1015R BBBA1018G BBBA1019E
Other devices under the same FDA submission
6 devices cleared under K951843 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- FMS 284508Medos International Sàrl · ARTHROSCOPE304 reports
- FMS 284504Depuy Mitek, LLC · ARTHROSCOPE81 reports
- FMS 281142Medos International Sàrl · ARTHROSCOPE38 reports
- FMS 284649Medos International Sàrl · ARTHROSCOPE34 reports
- FMS 284610Medos International Sàrl · ARTHROSCOPE20 reports
- FMS 281103Medos International Sàrl · ARTHROSCOPE6 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 57385).
- Z-1946-2011 · TerminatedDePuy Mitek FMS Irrigation Intermediary Tube With One-way Valve Arthroscopy tubing Product Code: 281142 Fluid Tissue Management
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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