Z-1251-2014Class II

Natural-Knee II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM UN CONG TIB INS SZ1/2 11MM U CONG...

Name: Z-1251-2014 Natural-Knee II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM UN CONG TIB INS SZ1/2 11MM U CONG...
Creator: Zimmer, Inc.
Published: 2014-02-25
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-02-25 / Terminated / root cause: packaging

FDA source

Zimmer, Inc. began a recall of Natural-Knee II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM UN CONG TIB INS SZ1/2 11MM U CONG TIB INS SZ1/2 13MM U CONG TIB INS SZ3/4 9MM UN... on 2014-02-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1251-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-25
Posted: 2014-03-20
Terminated: 2015-03-24
Recalling firm: Zimmer GmbH
Product: Natural-Knee II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM UN CONG TIB INS SZ1/2 11MM U CONG TIB INS SZ1/2 13MM U CONG TIB INS SZ3/4 9MM UN CONG TIB INS SZ3/4 11MM U CONG TIB INS SZ3/4 13MM U CONG TIB INS SZ 5/6 9MM U CONG TIB INS SZ5/6 11MM U CONG TIB INS SZ5/6 13MM U
Product code: HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
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.
Root cause tag: packaging
FDA 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 [email protected]. 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 in commerce: 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.
Product codes and lots: Item Number 611001009 611001011 611001013 611002009 611002011 611002013 611003009 611003011 611003013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1251-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1248-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-20
Z-1249-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-20
Z-1250-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-20
Z-1251-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-20
Z-1252-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-20
Z-1253-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-20
Z-1254-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-20
Z-1255-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-20
Z-1256-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-20
Z-1257-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-20
Z-1258-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-20
Z-1259-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-20
Z-1260-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-20
Z-1261-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-20
Z-1262-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-20

Product code HRY

K955778Class IINatural-Knee II Unicompartmentalknee SystemIntermedics Orthopedics / cleared 1996-03-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)