Skeletal Kinetics Recalls SKAFFOLD CMF Impress Bone Void Filler Kits
Skeletal Kinetics is recalling 12 units of SKAFFOLD CMF Impress bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.
What this means for you
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 is classified as FDA Class II, and the source text describes potential serious health consequences such as nonunion and lack of bone formation, but does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Skeletal Kinetics, LLC is recalling 12 units of SKAFFOLD CMF Impress (MP), 10CC bone void filler kits (Product Number: CMMP-IM10, UDI: 813845020696). The affected lot number is 1141474. The product is indicated to fill bony voids or gaps of the skeletal system, including those in extremities, spine, and pelvis.
The recall was initiated because the bone void filler kits may not maintain their setting characteristics for the labeled shelf-life duration. The distribution pattern includes worldwide distribution and US nationwide distribution in specific states (AL, CA, CO, FL, IL, MO, MS, OH, OK, OR, TN, TX, WI) and countries (Australia, Canada, South Africa, Switzerland).
Use of the affected product may increase the required surgical and anesthesia time for the patient. Possible longer-term health consequences could include incomplete bone formation, lack of bone formation, delayed union, or nonunion. Healthcare providers and patients should contact Skeletal Kinetics for further instructions regarding the return or replacement of the product.
The recalled product
- Product
- SKAFFOLD CMF IMPRESS (MP), 10CC. Product Number: CMMP-IM10, UDI: 813845020696 - 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 crea
- Manufacturer
- Skeletal Kinetics, Llc
- Affected units
- 12
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 (1)
- Lot Number: 1141474.
Distribution
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.
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