| Class 2 Device Recall Persona Trabecular Metal Tibial Plate / Persona TM Tibia | |
Date Initiated by Firm | January 28, 2015 |
Date Posted | March 12, 2015 |
Recall Status1 |
Terminated 3 on March 13, 2018 |
Recall Number | Z-1266-2015 |
Recall Event ID |
70523 |
510(K)Number | K121771 |
Product Classification |
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
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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. |
Code Information |
All lots and sizes; Sizes C-J Left and Right. |
Recalling Firm/ Manufacturer |
Zimmer, Inc. 1800 W Center St Warsaw IN 46580-2304
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For Additional Information Contact | 1800-447-5633 |
Manufacturer Reason for Recall | An increase in complaints of loosening and radiolucent lines. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | 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. |
Quantity in Commerce | 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: PROSTHETICS DEPT TOGUS ME 04330 207-672-9425
HOSPITAL VA MED CTR (438) 2501 W 22 SIOUX FALLS, SD 57105 605-336-8922
HOSPITAL VA MED CTR (509)1 FREEDOM WAY AUGUSTA , GA 30904 706-721-6892
HOSPITAL VA MED CTR (521) 700 S 19TH ST, BIRMINGHAM, AL 35233 378-962-1599
HOSPITAL VA MED CTR (523) 1400 VFW PARKWAY, WEST ROXBURY, MA 02132 617-862-5977
HOSPITAL VA MED CTR (528) 3495 BAILEY AVENUE BUFFALO, NY 14215 716-898-6922
HOSPITAL VA MED CTR (552) 4100 WEST 3RD STREET BLDG # 330 RECEIVING, DAYTON, OH 45428 937-226-5987
HOSPITAL VA MED CTR (583), 1481 WEST 10TH STREET INDIANAPOLIS, IN 46202 317-267-8765
HOSPITAL VA MED CTR (595) 1700 SOUTH LINCOLN AVENUE, LEBANON, PA 17042 717-272-6621
HOSPITAL VA MED CTR (657) 915 N GRAND BLVD, ST LOUIS, MO 63106 314-652-4100
HOSPITAL VA MED CTR (664) 350 LA JOLLA VILLAGE DR SAN DIEGO, CA 92161 858-552-8585
HOSPITAL VA MED CTR (693) 1111 EAST END BOULEVARD, WILKES BARRE, PA 18711 717-824-3521
HOSPITAL VA SNHCS (654/118) 975 KIRMAN AVENUE RENO NV 89502 702-597-1699 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MBH
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