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

Recall number

Z-1249-2014

Recalling firm

Zimmer, Inc.

Product

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

Status

Terminated

Initiated

2014-02-25

Posted

2014-03-20

Terminated

2015-03-24

Reason

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.

Root cause

Storage

Action

Beginning 2/25/2014 all distributors were notified via electronic mail. Hospital risk managers and distributors, surgeons with affected inventory will also be notified via courier or direct mail. The Urgent Lot Specific Recall Notice identified the issue and responsibilities. Distributors were asked to locate and remove the affected product in their territory, as well as identifying hospitals and surgeons who have previously implanted the affected product. Distributors were asked to return on-hand affected products to Zimmer and ensure all of their products are accounted for using the form provided in the letter and email it back to corporatequality.postmarket@zimmer.com. Hospital risk managers and surgeons were asked to locate affected product and return it to their Zimmer sales representative. Questions or concerns should be addressed to customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST Communications outside of the United States will occur approximately two weeks after the United States communications. 100 % effective checks will be done.

Quantity

3638 units

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.

Lot, serial or model codes

Item Number 00591101128 00591101137

510(k) numbers

["K936159"]

PMA numbers

not on file

Product code

JWH

Firm FEI

1000220733

Firm city

Warsaw

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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