FDAAugust 8, 2018device
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.
What to do
FDA enforcement status: Terminated
Brands named
implant direct sybron manufacturingimplantimplant direct
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- CPSCPressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and Electrocution Hazards; Imported by Patoolio Direct2026-04-16
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- FDAHandy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd2026-02-18
- CPSCFortemotus Direct Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails2026-02-12
- CPSCWatkins Manufacturing Recalls Hydromassage Rotary Jets in Highlife Collection Spas Due to Entanglement and Drowning Hazards2026-02-12
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