The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2593-2020·Announced 2020-07-22

Skeletal Kinetics Recalls Acumed Callos Bone Void Filler Kits

Skeletal Kinetics is recalling Acumed Callos bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm medical device where potential injury (delayed union, nonunion) has not yet been reported, fitting the High severity criteria.

Plain-English summary

Skeletal Kinetics, LLC is recalling 184 units of Acumed Callos Inject 3CC bone void filler kits. The product is indicated to fill bony voids or gaps in the skeletal system, including extremities, spine, and pelvis. The recall covers specific lot numbers distributed worldwide, including in the United States and several international countries.

The recall was initiated because the bone void filler kits may not maintain their setting characteristics for the labeled shelf-life duration. If the product fails to set properly, it may increase the required surgical and anesthesia time for the patient. Potential longer-term health consequences include incomplete bone formation, lack of bone formation, delayed union, or nonunion.

Healthcare providers and patients who have used or have these specific lot numbers of Acumed Callos should contact Skeletal Kinetics for further instructions on how to proceed. The affected lot numbers are 17091305, 17091304, 17091303, 17101916, 17110325, 1126148, 1129604, and 1135939.

The recalled product

Product
ACUMED CALLOS INJECT 3CC. Product Number: 65-0003-S, UDI: 813845020221 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created…
Manufacturer
Skeletal Kinetics, Llc
Category
Medical Device — Bone Void Filler
Hazard
Affected units
184

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • Lot Numbers: 17091305
  • 17091304
  • 17091303
  • 17101916
  • 17110325
  • 1126148
  • 1129604
  • 1135939.

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Part of a larger recall action

This product is one of 45 recalled by Skeletal Kinetics, Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 45 products in this recall →

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