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U.S. Department of Health and Human Services

Class 2 Device Recall Versafitcup Total Hip SystemImpacting Ring

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 Class 2 Device Recall Versafitcup Total Hip SystemImpacting Ring see related information
Date Posted February 23, 2013
Recall Status1 Terminated on February 23, 2013
Recall Number Z-0878-2013
Recall Event ID 64294
510(K)Number K083116 
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
Product 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.
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.
Recalling Firm/
Manufacturer
Medacta Usa Inc
4725 Calle Quetzal Ste B
Camarillo CA 93012-8429
For Additional Information Contact
858-705-0350
Manufacturer 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.
FDA Determined
Cause 2
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 in Commerce 293 units
Distribution Nationwide Distribution including the states of ID, CO, TX, WI, NY, CT, WA, CA, UT, and AZ.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MEH and Original Applicant = MEDACTA INTERNATIONAL, SA
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