Reported Mar 25, 2020 · Terminated
OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions:…
Xtant Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: XTANT MEDICAL INC · 664 Cruiser Ln · Belgrade, MT · 59714-9719
Is this the product you have?
- OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R
- Product Code359100
- DimensionsONE(1) PACKAGE - CONTAINING 10.0cc
- UDI00849777003681 -
- Product UsageOsteoSelect 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
- Lot codes and dates
- Lot/Serial numbersB180228-751 through B180228-779
- Model/Product Code359100;the expiration date of these devices is 2021-06-05
- Amount recalled
- 26
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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