Device Recall Synthes 2.4 and 2.7 MM Locking Screw SLFTPNG with T8 Stardrive Recess 12 MM 의 리콜

Recall

66411

Class 2

Z-0380-2014

2013-07-31

2013-11-22

Terminated

United States

2016-08-18

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122355

Specific lots of the ss 2.4mm and ss 2.7mm locking screw (self-tapping) due to a mislabeling issue. the ss 2.7mm screw was labeled as ss 2.4 mm screw.

Synthes sent an URGENT NOTICE: MEDICAL DEVICE RECALL letter dated July 31, 2013, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 if they have any of the affected product to obtain a Return Authorization Nuber, complete the Verification Section at the end of the letter by checking the appropriate box indicating affected product has been located, also indicate the number of devices found and note the Return Authorization Number. Fax the documents to Synthes at 1-866-792-6446 or email to FieldAction@synthes.com. Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.