Natural-knee¿ II System Ultra Cong INS LT Sza/9mm Ultra recall
Natural-Knee¿ II System ULTRA CONG INS LT SZA/9MM ULTRA CONG INS LT SZA/13M ULTRA CONG INS LT SZA/19M ULTRA CONG INS RT SZA/9MM ULTRA CONG INS RT…
Why was Natural-knee¿ II System Ultra Cong INS LT Sza/9mm Ultra 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 625001609 625001613 625001619 625001709 625001711 625001713 625001719 625002613 625002616 625002719 625002722 630809510 630811410 630811510 630813410 630813510 630816210 630816410 630816510 630819010 630819110 630819210 630819310 630819410 630819510 635000009 635001009 635001011 635001111 635001116 635002009 635002011 635002109 635002111 635002113 635003009 635003011 635003013 635003016 635003109 635003113 635003116 635004009 635004011 635004016 635004111 635004113 635004119 635005013 635005019 635005111 635005116 635006109 670501916 670501919 670503819 670503911 670503916
- Product
- Natural-Knee¿ II System ULTRA CONG INS LT SZA/9MM ULTRA CONG INS LT SZA/13M ULTRA CONG INS LT SZA/19M ULTRA CONG INS RT SZA/9MM ULTRA CONG INS RT…
- 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)