CLASS II Device recall · Reported 27 Aug 2014 · FDA Enforcement Report
Vanguard 360 Femoral Boss Reamer, Label recalled by Biomet
Biomet is recalling Vanguard 360 Femoral Boss Reamer, Label, distributed in 34 states. The recall was initiated on 1 Jul 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2242-2014
- FDA event ID
- 68931
- Recalling firm
- Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jul 2014
- FDA classified
- 15 Aug 2014
- Reported
- 27 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 1 Jul 2014 | Recall initiated by company | |
| 15 Aug 2014 | Classified by FDA | +45 days |
| 27 Aug 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
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
AlabamaArkansasArizonaCaliforniaColoradoFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMissouriMontanaNorth CarolinaNew Hampshire
Questions about this recall
Why was it recalled?
The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.
Which lots are affected?
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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |