Device Recall Surgical Blade 의 리콜

Recall

58013

Class 2

Z-1880-2011

2010-11-30

2011-04-04

Terminated

United States

2011-11-09

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97969

On nov 30, 2010 conmed linvatec, largo, fl recalled their micro sagittal blade, fine lot number 180209, product number 5023-138. some units of micro sagittal blade, fine from lot 180209 may have compromised seals in the sterile packaging.

Linvatec Corp. dba ConMed sent an Urgent Medical Device Recall Notification letter dated November 30, 2010, by FedEx, email, Fax, etc) to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the reply form within 30 days of receipt. Immediately check their facility's inventory for the affected product and lot number. If they had any of the product with lot number 180209. Do Not Use. Segregate and return for credit. If the product was transferred to another facility, customers were to complete the REPLY FORM documenting the transfer of the product and fax the form to 727-319-5701. For questions regarding this recall call 727-319-5701 or 800-535-8536.