Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ recall
Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 5; 00-7713-005-00
Why was Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ 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?
61930610 61967651 62010520 62053333 62430587 62460391 62503140 62794209 62876154 62927048 63034172 63034173 63034174 63038714 63076525 63081182 63128514 63128518 63161307
- Product
- Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 5; 00-7713-005-00
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 227
- Distribution
- Products were distributed solely to Japan.
- Recall date
- July 11, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)