Zimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7711-004-10
Published July 11, 2018 · Recall initiated: May 30, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- Products were distributed solely to Japan.
- Lot
- 62107667 62410983 62410984 62445410 62449677 62450635 62469393 62478848 62478852 62478855 62503181 62547038 62554172 62559999 62560152 62577929 62630007 62636746 62652981 62659334 62667678 62753395 62770876 62777941 62791158 62806022 62897465
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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