Recall archive
4 recalls · page 1 of 1
Reported Jan 27, 2021
OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - Product Usage: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Skeletal Kinetics, LLC
Matched: Brand — A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 22, 2020
ACUMED CALLOS INJECT 10CC. Product Number: 65-0010-S, UDI: 813845020245 - Product Usage: Callos is indicated to fill…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Skeletal Kinetics, LLC
Matched: Brand · Product details — Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and…
44 more products in this recall
FDA (openFDA device enforcement)
Reported May 27, 2020
Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Skeletal Kinetics, LLC
Matched: Brand · Product details — Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc that may not have been sterilized was inadvertently…
FDA (openFDA device enforcement)
Reported Aug 5, 2015
InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler. Sterilized…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Skeletal Kinetics, LLC
Matched: Brand · Product details — Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone Void Filler.
FDA (openFDA device enforcement)
RecallNow is not a government agency. Every notice above is published by the FDA, USDA FSIS, or CPSC and links back to its source. Back to the look-up