Rappel de Device Recall Synthes Small Electric Drive (SED)

Recall

69753

Class 2

Z-0931-2015

2014-11-06

2015-01-07

Terminated

United States

2015-08-17

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131465

The device may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. unintended start of the hand piece or wrong mode/direction could cause bone/soft tissue, peripheral nerve, and /or vascular damage. injuries may need surgical or medical intervention. surgical delay and postoperative local infection are also potential risks.

DePuy Synthes sent an Urgent Notice: Medical Device Removal letter dated November 6, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify their consignees using the hospital personnel letter, dated November 6, 2014, as their template for their consignee notification letter, review their inventory and remove the affected lots from stock. Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. Complete the Verification Section (page 4 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, address, telephone number and signature in the spaces provided. Return the Verification Section (page 4 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Send a copy of the completed Verification Section to DePuy Synthes by: Fax: (610) 430-7083 or Scan/email: Fieldaction@synthes.com If you DO NOT have the identified product, please take the following steps: Complete the attached Verification Section (page 4 of this letter) by checking the appropriate box indicating that no affected product has been located. Please include your name, title, address, telephone number and signature in the spaces provided. This return documentation acknowledges your receipt of medical device removal information. Return the documents to DePuy Synthes by: Fax: (610) 430-7083 or Scan/email: Fieldaction@synthes.com Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 4 of the notification. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.