FDA Recall Terminated

Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0137 (54mm), 01.26.10.0138 (56mm), 01.26.10.0139 (58mm), 01.26.10.0140 (60mm), 01.26.10.0141 (62mm), 01.26.10.0142 (64mm). Designed for cementless use in total hip arthroplasty.

Recall: Z-0878-2013 · Initiated January 15, 2010

Recall

Recall Number: Z-0878-2013
Event Number: 64294
Firm: Medacta Usa Inc
FEI Number: 3006639916
Product Code: MEH
Status: Terminated
Root Cause: Process control
Initiated: January 15, 2010
Posted: February 23, 2013
Terminated: February 23, 2013
Address: 4725 Calle Quetzal, Ste B, Camarillo, CA, 93012-8429

Description

Reason

Medacta USA is recalling Versafitcup Impacting Ring because the impaction ring may not fit properly in the implant shell in all cases. This could result in surgical delay potentially increasing possible complications under anesthesia, having to ream up to a larger shell size leaving less bone than planned and repositiong/removal of the shell after initial impaction.

Action

Medacta USA sent notification letters dated 1/15/10 to Sales Representatives for customers that purchased the Versafitcup Impacting Ring. The letter informed the customers of the problem identified and the actions to be taken. Customers are informed that Medacta USA personnel will contact them by telephone to provide them with a RMA number. Customers are informed that they will receive a new set of redesigned/reworked impacting rings and a second near the end of the January 2010. Customers with questions are instructed to contact the firm at (805) 437-7085.

Distribution

Nationwide Distribution including the states of ID, CO, TX, WI, NY, CT, WA, CA, UT, and AZ.

Quantity

293 units