Recalls / —
—#132056
Product
Synthes Small Electric Drive (SED)
- FDA product code
- HTC — Pliers, Surgical
- Device class
- Class 1
- Medical specialty
- General, Plastic Surgery
- Affected lot / code info
- All lots from production launch
Why it was recalled
May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.
Root cause (FDA determination)
Other
Action the firm took
On November 13, 2014 DePuySynthes sent a letter to all their consignees informing them of the recall and asked them to return the product. A letter and a response letter were sent to all customers that received the device. For contact - The Complaint Handling Unit Manager at 561-494-3673 or the customer DePuy Synthes Sales Consultant.
Recalling firm
- Firm
- The Anspach Effort, Inc.
- Address
- 4500 Riverside Dr, Palm Beach Gardens, Florida 33410-4235
Distribution
- Distribution pattern
- CO, FL, LA, ID, CA, KS, IL, TX, VA, MI, NC, WA, AR, NY, NC, AZ, and Hawaii Canada, Hong Kong, Chile, Israel, Poland, Turkey, Itly, Malaysia, Ireland, Korea, Germany, Spain, Norway, Sweeden, England, Fiji, Switzerland, Belgium, Austria, Netherlands, France, Japan, China, India, Thailand, Russia, Zaire, Taiwan, and Australia.
Timeline
- Recall initiated
- 2014-11-14
- Posted by FDA
- 2016-02-25
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #132056. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.