Recalls / —
—#87925
Product
Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S.
- FDA product code
- HRS — Plate, Fixation, Bone
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K021458
- Affected lot / code info
- All lots.
Why it was recalled
There is the potential for the bender/cutter attachment to continue heating after release of the power button. There is potential for patient and/or staff injury if continuous heating is unrecognized.
Root cause (FDA determination)
Other
Action the firm took
An "Urgent: Medical Device Recall" letter dated January 8, 2010 was issued to customers via USPS Certified mail. The letter described the issue and affected product. Customers were notified to cease use of the recalled product, examine inventory and follow instructions for return to the firm as indicated in the recall letter. For questions, please call 1-800-620-7025 x 5452 or 1-610-719-5452 or contact your Synthes CMF Sales Consultant.
Recalling firm
- Firm
- Synthes USA (HQ), Inc.
- Address
- 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417
Distribution
- Distribution pattern
- Nationwide Distribution.
Timeline
- Recall initiated
- 2010-01-06
- Posted by FDA
- 2010-02-24
- Terminated
- 2010-10-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #87925. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.