10 mm/135 degree Titanium Cannulated Trochanteric recall
10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal…
Why was 10 mm/135 degree Titanium Cannulated Trochanteric recalled?
The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction and construct stability which may lead to non-union/malunion.
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?
part number: 456.316S, lot number: 7782247
- Product
- 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal…
- Recalling firm
- Synthes, Inc.
- Quantity
- 6
- Distribution
- US Distribution in the states of: AK, FL, OH, OK, and TX.
- Recall date
- November 26, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)