Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET O
FDA device recall Z-2242-2014 · posted 2014-08-15 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.
- Action taken
- Urgent Medical Device Recall Notices dated July 15, 2014 were mailed with verification of delivery via FedEx. Response forms were provided to all consignees in order for Biomet to track returns. The letters informed the consignees to return the devices to Biomet and conduct a sub-recall sending the recall letter to all customers.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 461
- Distribution
- California, IA, FL, MD, UT, SC, AL, IL, CO, MA, KS, GA, WA, NV, AR, NH, OK,Pennsylvania, New York, Texas, Virginia, New Jersey, North Carolina, Kentucky, Michigan, Ohio, Wisconsin, Louisiana, Arizona,
- Date initiated
- 2014-07-01
- Date posted
- 2014-08-15
- Date terminated
- 2015-10-30
- Location
- Warsaw, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VANGUARD 360 REVISION KNEE SYSTEM (K093293) | Biomet, Inc. | 2010-10-22 |