Zimmer, Inc.: Natural-Knee¿ N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1

Is my product affected?

Natural-Knee¿ N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1

• UPC 00591101128
• UPC 00591101137

Check against the official notice below — it lists the full affected range.

What happened

Zimmer, Inc. is recalling 3,638 units of Natural-Knee N-K II Domed All-Poly Patella components (Item Numbers 00591101128 and 00591101137) due to discoloration of the All Poly Tibia component. The discoloration resulted from free radical oxidation that occurred prematurely because the machined component was stored in a transparent container exposed to artificial light for six years before being placed in inert packaging and sterilized.

The affected products were distributed worldwide, including throughout the United States and in Canada, Australia, India, Austria, Japan, Czech Republic, South Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland. The source record does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.

Details from the source

Reason for recall: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device. Distribution: Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland. Quantity: 3638 units Lot/code info: Item Number 00591101128 00591101137

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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