Recalls / —
—#74810
Product
Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing, Model number 0350600006, for use with the FloControl Arthroscopy Pump.
- FDA product code
- HRX — Arthroscope
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K944210
- Affected lot / code info
- Lot number: 08E0451
Why it was recalled
Unable to pump fluids. Silicone tubing is stiffer than usual, resulting in motor defect message, leading to inability to pump saline through tubes for surgery.
Root cause (FDA determination)
Process control
Action the firm took
Stryker Endoscopy initiated the recall 10/01/2008. Information gathered and recall packets sent via FedEx to all affected accounts. Packets included advisory notices and acknowledgement card, as well as shipping labels to return product. Each account was instructed to locate and quarantine product for return to Stryker endoscopy. Sales representatives received a voicemail/email notification that included a list of all affected accounts.
Recalling firm
- Firm
- Stryker Endoscopy
- Address
- 5900 Optical Ct, San Jose, California 95138-1400
Distribution
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2008-10-01
- Posted by FDA
- 2009-01-21
- Terminated
- 2010-12-16
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #74810. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.