ITST intertrochanteric/subtrochanteric fixation 4.5 mm recall
ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745
Why was ITST intertrochanteric/subtrochanteric fixation 4.5 mm recalled?
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
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?
LOT: 63275969
- Product
- ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745
- Recalling firm
- Zimmer Manufacturing B.V.
- Quantity
- 50
- Distribution
- Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
- Recall date
- May 25, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)