Natural-Knee¿ Congruent Tibial Insert with Screw recall
Natural-Knee¿ Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 SF-CON TIB INS RT SZ1/2 9 SF-CON TIB INS RT SZ3/4/5
Why was Natural-Knee¿ Congruent Tibial Insert with Screw 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item Number 620005819 620005909 620006916
- Product
- Natural-Knee¿ Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 SF-CON TIB INS RT SZ1/2 9 SF-CON TIB INS RT SZ3/4/5
- Recalling firm
- Zimmer, Inc.
- 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.
- Recall date
- March 26, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)