TaperFit Stem recall
TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
Why was TaperFit Stem recalled?
Some of the devices did not pass fatigue testing.
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?
Model #588.3800, Lot #494754; UDI 05055343871065
- Product
- TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
- Recalling firm
- Corin Ltd
- Quantity
- 1
- Distribution
- Distribution was made to NJ. There was no military/government distribution.
- Recall date
- September 7, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)