Health product recall

Skaffold Next Generation Bone Void Filler 5CC, 10CC (2020-04-02)

Starting date:
April 2, 2020
Posting date:
June 26, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-73423

Last updated: 2020-06-29

Affected Products

Skaffold Next Generation Bone Void Filler 5CC, 10CC

Reason

According to results from shelf-life testing, the product does not appear to maintain its setting characteristics for the labeled 30 or 36-month shelf-life of the product,

Affected products

Skaffold Next Generation Bone Void Filler 5CC, 10CC

Lot or serial number
  • 16120102
  • 17011801
  • 17020201
Model or catalog number
  • SKMX-FL05
  • SKMX-FL10
Companies
Manufacturer

SKELETAL KINETICS LLC

10201 BUBB ROAD

CUPERTINO

95014

California

UNITED STATES