Recall Z-1266-2015
Zimmer, Inc. · initiated January 28, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer For use in either posterior cruciate retaining or sacrificing surgical procedures.
Codes / lots: All lots and sizes; Sizes C-J Left and Right.
Reason for recall
An increase in complaints of loosening and radiolucent lines.
FDA-determined cause: Under Investigation by firm
Action taken
Zimmer Inc. is initiating a voluntary recall of Persona Trabecular Metal Tibial following an increase in complaints of radiolucent lines and loosening. All sizes and lots of the affected devices are being removed from distribution. Urgent Medical Device Recall notices were issued to affected distributors, hospitals, and surgeons on 2/16/2015 via mail. Customers are asked to review the notification and ensure affected personnel are aware of the contents. All affected product are to be located and quarantined immediately. The Inventory Return Certification Form should be completed and returned along with the recalled product. Customers may contact the following with any questions: 1-877-946-2761 between 8:00 am and 5:00pm EST.
Details
- Recall number
- Z-1266-2015
- Initiated
- January 28, 2015
- Posted by FDA
- March 12, 2015
- Terminated
- March 13, 2018
- Product code
- MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Quantity
- 11,658
- Distribution
- Worldwide Distribution -- US, including the states of AK, AL, AZ, CA, CO, FL, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, and WI; Foreign:Canada, Australia, New Zealand, Korea, Austria, Belgium, Germany, Italy, Luxembourg, Netherlands, South Africa, Sweden, Switzerland, and United Arab Emirates. DOD/VA: HOSPITAL- VA MAINE HLTCR SYTM (402) VA MROC (402) ATTN:…
- Recalling firm
- Zimmer, Inc., Warsaw, IN