Device product
Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581 USA
Z-2242-2014
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 68931
- Status
- Terminated
- Classification
- Class II
- Quantity
- 461
- Official record key
device-enforcement:Z-2242-2014
Official wording
Reason: The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.
Code information: Catalog Number: 32-48847 4 Lot Numbers: 022120, 022180, 162530, 232460, 475500 and 475510. 699240, 793350, 793570 Additional Scope: 065030, 095780, 164290, 235870, 253670, 273630, 308620, 418970, 420030, 421210, 570460, 585260, 619690, 708240, 711430, 726490, 816160, 896810, 929690, 953540, 968950
Distribution pattern: 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, Indiana, South Dakota, Missouri & Montana. In addition to Korea, B.V., Japan, Puerto Rico, UK, Chile, New Zealand, Australia, & Canada
Derived failure modes
-
Unknown
The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.