Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged recall
Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
Why was Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged recalled?
A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requested by a surgeon. After the device was manufactured and used in the planned surgery, it was discovered internally that the implant assembly had a CoCrMo screw included as a component of the implant, which contains nickel.
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: CP116574 Lot Number: 073840
- Product
- Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 1
- Distribution
- This was a custom implant, there was only one (1) unit manufactured and distributed. The product has been implanted, so it is not subject to being returned.
- Recall date
- November 15, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)