FDA Device recall Z-2361-2018
Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-7711-004-40
- FDA Device
- Class II
- terminated
- Published 2018-07-11
On 2018-07-11 the FDA classified a Class II recall of Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-7711-004-40 by Zimmer Biomet, citing 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 o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2361-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-30 |
| Published | 2018-07-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | n/a |
Product
Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-7711-004-40
Reason
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.
Identifiers
| code_info | 61967700 62386066 62386068 62410987 62416627 62445412 62450669 62458974 62472166 62484291 62503192 62515309…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2361-2018%22
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