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.
FDA Recall Z-0878-2013 · Posted 2013-02-23
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Recalling FirmMedacta Usa Inc
Recall StatusTerminated
Product CodeMEH
Date Initiated2010-01-15
Date Terminated2013-02-23
Product Quantity293 units
Reason for Recall
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution including the states of ID, CO, TX, WI, NY, CT, WA, CA, UT, and AZ.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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