Zimmer Biomet recalls M/L Taper Hip Prosthesis (plasma sprayed, size 4) made before Oct 2015 due to potential black residue in polyethylene bags. This residue may delay surgery or cause wear from debris.
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.
Zimmer Biomet is recalling M/L Taper Hip Prosthesis implants made before October 2015 because they may contain black residue in the packaging. This residue could delay surgery or cause implant wear during procedures.
The black residue comes from titanium plasma spray used to create the implant's porous surface mixing with the polyethylene bag. This residue is biocompatible but may cause delays in surgery or lead to implant wear if debris enters the joint.
Patients who received the recalled implants before October 2015 are affected. Those with the specific model numbers listed in the recall are most at risk.
Check for the model numbers listed in the recall (e.g., 62107667, 62410983) on the implant packaging. The implants were manufactured before October 2015.
Look for the model numbers listed in the recall on the implant's packaging or documentation.
The recall states the residue is biocompatible, but it may cause delays in surgery or lead to implant wear if debris enters the joint.
The black residue is a combination of titanium plasma spray and polyethylene bag material that may cause delays in surgery or implant wear.
The recall does not specify a remedy, so no action is required unless you have the listed model numbers and were implanted before October 2015.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2362-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-2362-2018 from Zimmer Biomet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.