||March 08, 2013
||REF S313152 Straight Acetabular Inserter Handle Ringloc
Orthopedic manual surgical instrument
||Catalog Number 5313152
Lot 153880,153930, 415500, 648010
56 E Bell Dr
Warsaw, Indiana 46582-6989
||Contact the recalling firm for information
|For Additional Information Contact
574-267-6639 Ext. 1676
|The Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of the tolerance causing interference with the Ringloc cup. The inserter handle may lock onto the cup during impaction. If alternative inserters are not available this could cause a surgical delay greater than 30 minutes.
||BIOMET sent an Urgent Recall Notice beginning February 13, 2013, to all affected customers. The notice included possible adverse events and directions to locate and remove identified devices by returning a Fax Back Response Form to 574-372-1683 and obtaining an RGA # prior to return of product to Biomet, Inc. 56 East Bell Drive Warsaw, IN 46580. Questions should be directed to 574 372-1570 M-F, 8 a.m.-5.p.m.
For questions regarding this recall call 574-267-6639, ext 1676.
|Quantity in Commerce
||Worldwide Distribution - No USA distribution -Internationally to Canada, Japan, and Chile