Recalls / —
—#66399
Product
Stryker Disposable StrykeProbe 32cm L- Tip, Ref: 250-070-550, Electrosurgical Suction Tip, Stryker Endoscopy, San Jose, CA 95138.
- FDA product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K052141
- Affected lot / code info
- Lot Number: 07297FE2
Why it was recalled
Cannot connect: Tips have electrodes that are too large to fit monopolar cables and are unusable.
Root cause (FDA determination)
Device Design
Action the firm took
Stryker notified their sales representatives by phone. Stryker sent all consignees a Product Advisory Notice dated November 19, 2007, and verbally notified them of the recall via telephone. A response form with return postage was sent with the notice. The letter requested the hospitals to quarantine and return the product to Stryker.
Recalling firm
- Firm
- Stryker Endoscopy
- Address
- 5900 Optical Ct, San Jose, California 95138
Distribution
- Distribution pattern
- Nationwide Distribution.
Timeline
- Recall initiated
- 2007-11-16
- Posted by FDA
- 2008-03-05
- Terminated
- 2008-03-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #66399. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.