CLASS II Device recall · Reported 26 Mar 2014 · FDA Enforcement Report
Natural-Knee¿ II System: Poly Ultra Tib LT SZ00/9M Poly recalled
Zimmer is recalling Natural-Knee¿ II System: Poly Ultra Tib LT SZ00/9M Poly Ultra Tib LT SZ0/ Poly Ultra Tib, distributed nationwide in the US. The recall was initiated on 25 Feb 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1262-2014
- FDA event ID
- 67503
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Feb 2014
- FDA classified
- 20 Mar 2014
- Reported
- 26 Mar 2014
- Type
- Voluntary: Firm initiated
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 25 Feb 2014 | Recall initiated by company | |
| 20 Mar 2014 | Classified by FDA | +23 days |
| 26 Mar 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Natural-Knee¿ II System: POLY ULTRA TIB LT SZ00/9M POLY ULTRA TIB LT SZ0/9MM POLY ULTRA TIB LT SZ0/19M POLY ULTRA TIB RT SZ0/13M POLY ULTRA TIB RT SZ0/16M ALL POLY ULTRA TIB LT SZ1 ALL POLY ULTRA TIB RT SZ1 ALL POLY ULTRA TIB LT SZ2 ALL POLY ULTRA TIB LT SZ2 ALL POLY ULTRA TIB RT SZ2 ALL POLY ULTRA TIB LT SZ3 ALL POLY ULTRA TIB RT SZ3 ALL POLY ULTRA TIB RT SZ5
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaIllinoisIndianaKansasLouisianaMaineMichiganMissouriMississippiNorth CarolinaNorth DakotaNebraska
Questions about this recall
Is Natural-Knee¿ II System: Poly Ultra Tib LT SZ00/9M Poly Ultra Tib LT SZ0/ Poly Ultra Tib recalled?
Yes. Zimmer recalled Natural-Knee¿ II System: Poly Ultra Tib LT SZ00/9M Poly Ultra Tib LT SZ0/ Poly Ultra Tib on 25 Feb 2014. The recall is Class II and its status is Terminated. Recall number Z-1262-2014.
Why was it recalled?
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.
Which lots are affected?
Item Number 621800809 621801809 621801819 621801913 621801916 621810816 621810909 621820809 621820811 621820911 621830811 621830909 621850916
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |