PlainRecalls
FDA Devices Moderate Class II Terminated

11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal procedures.

Reported: June 9, 2021 Initiated: March 25, 2021 #Z-1717-2021

Product Description

11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal procedures.

Reason for Recall

Products distributed as sterile may not have been adequately sterilized

Details

Recalling Firm
Zavation
Units Affected
7 units
Distribution
US nationwide distribution.
Location
Flowood, MS

Frequently Asked Questions

What product was recalled?
11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal procedures.. Recalled by Zavation. Units affected: 7 units.
Why was this product recalled?
Products distributed as sterile may not have been adequately sterilized
Which agency issued this recall?
This recall was issued by the FDA Devices on June 9, 2021. Severity: Moderate. Recall number: Z-1717-2021.