Recall Z-0878-2013— Medacta Usa Inc

Name: FDA recall Z-0878-2013
Creator: U.S. Food and Drug Administration
Published: 2010-01-15

Class II · Terminated

Class II FDA medical device recall by Medacta Usa Inc, initiated 2010-01-15, terminated 2013-02-23. It names one FDA 510(k) clearance: K083116. 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.. 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..

Recalling firm: Medacta Usa Inc
Classification: Class II
Status: Terminated
Initiated: 2010-01-15
Terminated: 2013-02-23
Firm location: Camarillo, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K083116 — VERSAFIT CUP DOUBLE MOBILITY SYSTEMMedacta International S.A.·cleared 2009-04-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.