Vital MIS Spinal Fixation system implants CANN POLY EXT recall
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Number 810M5550 - Product Usage: are non-cervical spinal fixation devices…
Why was Vital MIS Spinal Fixation system implants CANN POLY EXT recalled?
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: (01)00887868324451; Lot Numbers: C19H0010 C19I0008 C19J0012 C19K0008 C20A0005 SBM108406 SBM118988 SBM122122
- Product
- Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Number 810M5550 - Product Usage: are non-cervical spinal fixation devices…
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 3235 total
- Distribution
- US nationwide distribution.
- Recall date
- June 10, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)