Retiro De Equipo (Recall) de Device Recall Synthes

Recall

65561

Class 2

Z-1745-2013

2013-05-31

2013-07-17

Terminated

United States

2015-08-31

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119576

Synthes is initiating a voluntary medical device removal for specified part numbers and lot numbers of the mutis vector distractor pin holding clamp, limited bone stock. the firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. it is not likely that a serious adverse event will result due to a nonconforming clamp, however there.

Synthes sent a Urgent Notice: Medical Device Removal letter dated May 31, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. The firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. It is not likely that a serious adverse event will result due to a nonconforming clamp, however, there is a remote potential that additional intervention would be required due to a non-functioning clamp. Synthes requested the product to be removed from inventory and returned to Synthes by calling 1-800-479-6329 to obtain a Return Authorization Number. Direct Accounts were asked to complete and return the Verification Section at the end of the letter indicating the quantity of affected product was found. Negative responses were also requested. If you have any questions please call (610) 719-5450.