Home / Recalls / Zimmer, Inc. / Z-1257-2014

Z-1257-2014 Class II Terminated

Recalled by Zimmer, Inc. — Warsaw, IN

FDA device recall Z-1257-2014 was initiated by Zimmer, Inc. on Feb 25, 2014 and is designated Class II. 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… The recall status is terminated (terminated Mar 24, 2015). Affected quantity: 3638 units.

Recall Details

Product Type: Devices
Report Date: Mar 26, 2014
Initiation Date: Feb 25, 2014
Termination Date: Mar 24, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3638 units

Product Description

Natural-Knee¿ II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS INS TIB SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ

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 Pattern

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.

Code Information

Item Number 672509100 672509101 672509200 672509203 672511100 672511103 672513101 672513103 672513201 672516103 672519103 672522201 672525103 672525203

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1257-2014
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Zimmer, Inc.

Z-2527-2026 Class II — Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide… (May 20, 2026)
Z-2531-2026 Class II — Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog… (May 20, 2026)
Z-2529-2026 Class II — Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide… (May 20, 2026)
Z-2528-2026 Class II — Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide… (May 20, 2026)
Z-2530-2026 Class II — Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog… (May 20, 2026)
Z-2578-2026 Class II — Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿… (May 11, 2026)
Z-1946-2026 Class II — Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and… (Mar 30, 2026)
Z-0970-2026 Class II — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus… (Dec 2, 2025)
Z-0980-2026 Class II — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus… (Dec 2, 2025)
Z-0972-2026 Class II — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus… (Dec 2, 2025)