Z-2361-2018 Class II Terminated
FDA device recall Z-2361-2018 was initiated by Zimmer Biomet, Inc. on May 30, 2018 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated May 28, 2020). Affected quantity: 280.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 11, 2018
- Initiation Date
- May 30, 2018
- Termination Date
- May 28, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 280
Product Description
Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-7711-004-40
Reason for Recall
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.
Distribution Pattern
Products were distributed solely to Japan.
Code Information
61967700 62386066 62386068 62410987 62416627 62445412 62450669 62458974 62472166 62484291 62503192 62515309 62594187 62601210 62615697 62622678 62636747 62665742 62681670 62740032 62797379 62797380 62882393 62917816 62114291R 77003795R
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2361-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026