Recall Z-1265-2016
Biomet, Inc. · initiated February 5, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
Codes / lots: Part number; Description; Lot number 195929 Vanguard XP Porous Femoral Rt 52.5 055330 195929 Vanguard XP Porous Femoral Rt 52.5 105710 195929 Vanguard XP Porous Femoral Rt 52.5 105820 195929 Vanguard XP Porous Femoral Rt 52.5 273570 195929 Vanguard XP Porous Femoral Rt 52.5 727260 195929 Vanguard XP Porous Femoral Rt 52.5 727280 195930 Vanguard XP Porous Femoral Rt 55 054980 195930 Vanguard XP Porous Femoral Rt 55 727270 195930 Vanguard XP Porous Femoral Rt 55 727290 195930 Vanguard XP Porous Femoral Rt 55 727310 195930 Vanguard XP Porous Femoral Rt 55 886090 195930 Vanguard XP Porous Femoral Rt 55 961570 195930 Vanguard XP Porous Femoral Rt 55 961580 195931 Vanguard XP Porous Femoral Rt 57.5 054700 195931 Vanguard XP Porous Femoral Rt 57.5 054760 195931 Vanguard XP Porous Femoral Rt 57.5 054990 195931 Vanguard XP Porous Femoral Rt 57.5 055340 195931 Vanguard XP Porous Femoral Rt 57.5 105720 195931 Vanguard XP Porous Femoral Rt 57.5 105730 195931 Vanguard XP Porous Femoral Rt 57.5 105830 195931 Vanguard XP Porous Femoral Rt 57.5 624770 195931 Vanguard XP Porous Femoral Rt 57.5 624940 195932 Vanguard XP Porous Femoral Rt 60 054770 195932 Vanguard XP Porous Femoral Rt 60 054780…
Reason for recall
The anterior/posterior (AP) dimension may be oversized by 0.016. If the femoral component does not fit as tightly as intended, bony ingrowth may not occur causing loosening of the femoral component. A revision surgery may be necessary.
FDA-determined cause: Device Design
Action taken
On 2/5/2016, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors, hospital risk managers, and implanting surgeons via courier. Distributors were instructed to locate and return the affected product, hospitals to locate and discontinue use, and implanting surgeons to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Details
- Recall number
- Z-1265-2016
- Initiated
- February 5, 2016
- Posted by FDA
- March 25, 2016
- Terminated
- March 28, 2017
- Product code
- MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Quantity
- 890
- Distribution
- UT Netherlands
- Recalling firm
- Biomet, Inc., Warsaw, IN