XTANT Medical Recalls OsteoSelect DBM Putty Due to Volume Discrepancy
XTANT Medical is recalling 26 units of OsteoSelect DBM Putty because three devices contained 5.0cc instead of the labeled 10.0cc.
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: The recall is classified as FDA Class II due to a labeling discrepancy (volume mismatch) which is a minor labeling error without reported injuries, fitting the Moderate severity criteria.
Plain-English summary
XTANT Medical Inc. is recalling 26 units of OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe (Product Code: 359100). The recall was initiated after the firm received one customer complaint regarding three devices that contained 5.0cc of putty instead of the 10.0cc stated on the label.
The affected devices are sterile bone void fillers and graft substitutes indicated for use in extremities, posterolateral spine, and pelvis. The specific lot numbers involved are B180228-751 through B180228-779, with an expiration date of June 5, 2021. The devices were distributed nationwide in Arizona, California, North Carolina, New Jersey, New York, Pennsylvania, South Carolina, Texas, and Washington.
Healthcare providers and patients should check their inventory for the affected lot numbers and stop using these devices. The FDA has classified this as a Class II recall, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI: 00849777003681 - Product Usage: OsteoSelect DBM Putty is indicated for use as a bone void filler and bone graft substitute…
- Manufacturer
- XTANT MEDICAL INC
- Hazard
- Affected units
- 26
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 (3)
- Lot/Serial numbers: B180228-751 through B180228-779
- Model/Product Code: 359100
- the expiration date of these devices is 2021-06-05.
Distribution
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