FDA Enforcement Class II 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 · Reported March 6, 2013

Enforcement

Recall Number: Z-0878-2013
Event ID: 64294
Classification: Class II
Status: Terminated
Product Type: Devices
Firm: Medacta Usa Inc
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: March 6, 2013
Initiation Date: January 15, 2010
Classification Date: February 22, 2013
Termination Date: February 23, 2013
Address: 4725 Calle Quetzal Ste B, N/A, Camarillo, CA, 93012-8429, United States

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.

Code Info

Reference Number Lot Number Reference Number Lot Number 01.26.10.0133: 095920, 096050, 096050A; 01.26.10.0138: 095925, 096055, 096055A; 01.26.10.0134: 095921, 096051, 096051A; 01.26.10.0139: 095926, 096056, 096056A; 01.26.10.0135: 095922, 096052, 096052A; 01.26.10.0140: 095927, 096057, 096057A; 01.26.10.0136: 095923, 096053, 096053A; 01.26.10.0141: 095928, 096058, 096058A; 01.26.10.0137: 095924, 096054, 096054A; 01.26.10.0142: 095929, 096059, 096059A.

Distribution

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

Quantity

293 units