APEX INTERFACE Hemi 54X and Flared 56X recall
APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is…
Why was APEX INTERFACE Hemi 54X and Flared 56X recalled?
The device may have improper screw hole placement due to inaccurate location of the index line.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
H5-12354: Lots - 20127 and 20167; H5-11356: Lot - 20097
- Product
- APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is…
- Recalling firm
- Omnilife Science Inc.
- Quantity
- 112
- Distribution
- US Nationwide Distribution in the states of IL, VA, CO, UT, NY, FL, MA, OK, CA, TN and WY.
- Recall date
- September 2, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)