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 for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoSelect DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect DBM Putty can be used as follows: - Extremities - Posterolateral spine - Pelvis.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot/Serial numbers: B180228-751 through B180228-779;Model/Product Code: 359100;the expiration date of these devices is 2021-06-05.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- XTANT MEDICAL INC
- Reason for Recall:
- The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (DBM) devices which contained 5.0cc of putty, instead of 10.00cc of putty as labeled.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoSelect DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect DBM Putty can be used as follows: - Extremities - Posterolateral spine - Pelvis.
Product Codes/Lot Numbers:
Lot/Serial numbers: B180228-751 through B180228-779;Model/Product Code: 359100;the expiration date of these devices is 2021-06-05.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1526-2020
Related Recalls
The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
Cervical Implants contain a label that incorrectly identifies the grade of titanium used.
The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.