Z-0878-2013 Class II Terminated
FDA device recall Z-0878-2013 was initiated by Medacta Usa Inc on January 15, 2010 and is designated Class II. 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 possi… The recall status is terminated (terminated February 23, 2013). Affected quantity: 293 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 6, 2013
- Initiation Date
- January 15, 2010
- Termination Date
- February 23, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 293 units
Product Description
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.
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.
Distribution Pattern
Nationwide Distribution including the states of ID, CO, TX, WI, NY, CT, WA, CA, UT, and AZ.
Code Information
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.