Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ recall
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 9; 00-7713-009-00
Why was Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ recalled?
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.
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?
62350575 62647167 62787292 63044896 63044897 63068905 63076554 63120523 63161387 63174034
- Product
- Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 9; 00-7713-009-00
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 116
- Distribution
- Products were distributed solely to Japan.
- Recall date
- July 11, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)