Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthes
FDA device recall Z-1265-2016 · posted 2016-03-25 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MBH
- Quantity affected
- 890
- Distribution
- UT Netherlands
- Date initiated
- 2016-02-05
- Date posted
- 2016-03-25
- Date terminated
- 2017-03-28
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL (K141407) | Biomet, Inc. | 2014-10-27 |