Recall Z-0878-2013 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Medacta Usa Inc
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.
| Date | Feb 23, 2013 (initiated Jan 15, 2010) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| 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. |
| Quantity | 293 units |
| Distribution | Nationwide Distribution including the states of ID, CO, TX, WI, NY, CT, WA, CA, UT, and AZ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083116 | VERSAFIT CUP DOUBLE MOBILITY SYSTEM Medacta International S.A., Apr 7, 2009 |