Femoral Integral Shaft & Stem 15x27 HA Coated recall
Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral…
Why was Femoral Integral Shaft & Stem 15x27 HA Coated recalled?
The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
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?
B10635, B11820, B12776, B10636, B10638, B9866
- Product
- Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral…
- Recalling firm
- Stanmore Implants Worldwide Ltd.
- Quantity
- 15 units
- Distribution
- Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
- Recall date
- December 28, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)