Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136
FDA device recall Z-0878-2013 · posted 2013-02-23 · Terminated
Recall details
- Recalling firm
- Medacta Usa Inc
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MEH
- Quantity affected
- 293 units
- Distribution
- Nationwide Distribution including the states of ID, CO, TX, WI, NY, CT, WA, CA, UT, and AZ.
- Date initiated
- 2010-01-15
- Date posted
- 2013-02-23
- Date terminated
- 2013-02-23
- Location
- Camarillo, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VERSAFIT CUP DOUBLE MOBILITY SYSTEM (K083116) | Medacta International S.A. | 2009-04-07 |