Synthes Small Electric Drive (SED)
FDA device recall Z-1017-2016 · posted 2016-02-25 · Open, Classified
Recall details
- Recalling firm
- The Anspach Effort, Inc.
- Reason for recall
- May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.
- Action taken
- 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.
- Root cause
- Other
- Status
- Open, Classified
- Product code
- HTC
- Quantity affected
- 302 (23 in the USA and 279 OUS)
- Distribution
- 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, F
- Date initiated
- 2014-11-14
- Date posted
- 2016-02-25
- Location
- Palm Beach Gardens, FL
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