Zimmer, Inc.: Gender Solutions" Natural-Knee¿ Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT

Is my product affected?

Gender Solutions" Natural-Knee¿ Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT

• UPC 00541800000
• UPC 00541800001
• UPC 00541800002

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

What happened

Zimmer, Inc. recalled 3,638 units of Gender Solutions Natural-Knee Flex System components (specifically All Poly Tibia components in three sizes) distributed worldwide across numerous U.S. states and international countries including Canada, Australia, India, Austria, Japan, and others. The recall was initiated after a complaint reported discoloration of an All Poly Tibia component, and investigation determined the discoloration resulted from premature free radical oxidation caused by six years of storage in a transparent container exposed to artificial light before the component was placed in inert packaging and sterilized.

The affected product lot/code numbers are 00541800000, 00541800001, and 00541800002. The recall record does not specify a remedy or instructions for what affected consumers should do.

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 Numbers 00541800000 00541800001 00541800002

Source

Official record: FDA (Device enforcement) ↗

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

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