Bone Graft Syringe Recall: Patient Chart Labels List Incorrect Part Numbers
Cerapedics is recalling putty i-FACTOR Peptide Enhanced Bone Graft syringes because patient chart labels contain incorrect Part Numbers and volume amounts. The company discovered the labeling discrepancy in 572 units distributed nationwide.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a Class III recall with no reported illnesses, injuries, or adverse events. The hazard is a documentation/labeling error on the patient chart containing incorrect Part Number and volume information. Per the rubric, documentation issues are classified as Score 1 (Low).
Plain-English summary
Cerapedics, Inc. is recalling 572 units of putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe (Model/Catalog Number 700-010, Lot Number 21C0991) due to incorrect labeling on patient charts.
The patient chart labels supplied with the product contain an incorrect Part Number and inaccurate volume amount. This discrepancy could create confusion regarding the correct product specification and quantity used during surgical procedures.
The affected syringes were distributed nationwide to healthcare facilities in Alabama, Arizona, California, Connecticut, Washington DC, Delaware, Idaho, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nevada, New York, Ohio, Pennsylvania, Texas, Virginia, and Washington.
Cerapedics advises healthcare facilities to verify the correct Part Number (700-010) and volume (1.0cc) on the product itself rather than relying on the patient chart label. Healthcare providers should correct patient records to reflect the accurate product information.
The recalled product
- Product
- putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
- Manufacturer
- Cerapedics, Inc.
- Category
- Medical Device — Bone Graft
- Hazard
- mis-labeling
- documentation-error
Distribution
Distributed nationwide across the United States.
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