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Open, Classified

Synthes Small Electric Drive (SED)

FDA Recall Z-1017-2016 · Posted 2016-02-25

Recalling FirmThe Anspach Effort, Inc.
Recall StatusOpen, Classified
Product CodeHTC
Date Initiated2014-11-14
Product Quantity302 (23 in the USA and 279 OUS)

Reason for Recall

May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.

Firm Action

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

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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