Recall Z-1700-2021— Zavation
Class II · Terminated
Class II FDA medical device recall by Zavation, initiated 2021-03-25, terminated 2023-03-20. It names 2 FDA 510(k) clearances: K141419, K130616. Product: 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures.. Reason: Products distributed as sterile may not have been adequately sterilized.
- Recalling firm
- Zavation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-03-25
- Terminated
- 2023-03-20
- Firm location
- Flowood, MS, United States
510(k) clearances named in this recall
2 on FDA's record- K141419 — ZVPLASTY
- K130616 — MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures.
Reason for recall
Products distributed as sterile may not have been adequately sterilized
Data sourced from openFDA. This site is unofficial and independent of the FDA.