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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Event Detail

Event ID 64294
Product Type Devices
Status Terminated
Recalling Firm Medacta Usa Inc
City Camarillo
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-01-15
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide Distribution including the states of ID, CO, TX, WI, NY, CT, WA, CA, UT, and AZ.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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. Class II 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. 293 units Z-0878-2013
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