APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Int
FDA device recall Z-2445-2015 · posted 2015-08-21 · Terminated
Recall details
- Recalling firm
- Omnilife Science Inc.
- Reason for recall
- The device may have improper screw hole placement due to inaccurate location of the index line.
- Action taken
- Omni sent an Urgent Medical Device Field Correction letter dated June 4, 2015 via email to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review inventory for affected product and complete and return the attached Acknowledgement and Receipt Form by FAX to 508-819-3390.
- Root cause
- Process design
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 112
- Distribution
- US Nationwide Distribution in the states of IL, VA, CO, UT, NY, FL, MA, OK, CA, TN and WY.
- Date initiated
- 2015-06-04
- Date posted
- 2015-08-21
- Date terminated
- 2015-09-28
- Location
- East Taunton, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM) (K112779) | Omnlife Science | 2011-12-02 |