Bone graft recalled over an incorrect expiration date on the label
Cerapedics is recalling 237 units of PearMatrix P-15 Peptide Enhanced Bone Graft, 1.0cc, over an incorrect expiration date.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 under the minor labeling criterion: the record cites an incorrect expiration date with no stated consequence or reported harm.
Plain-English summary
PearMatrix P-15 Peptide Enhanced Bone Graft, 1.0cc, REF 730-010, is being recalled by Cerapedics, Inc.
The reason given in the enforcement record is an incorrect expiration date.
The record lists 237 units from lot 7014819, UDI (01)00850001680196. Distribution was nationwide in the United States across the states listed in the enforcement record. The FDA has classified the action as Class II.
The record cites a printed date error and states no further consequence or reported injuries. Facilities should quarantine the affected lot and follow Cerapedics' instructions.
The recalled product
- Product
- PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010
- Manufacturer
- Cerapedics, Inc.
- Category
- Medical Device — Bone graft
- Affected units
- 237
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: 7014819/UDI: (01)00850001680196
Distribution
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