Vital MIS Spinal Fixation system implants CANN POLY EXT recall
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM, Item Number 810M5535 - 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)00887868324420; Lot Numbers: C19H0007 C19J0004 C19K0001 C19K0003 C20A0002 SBM108403 SBM118985 SBM122395
- Product
- Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM, Item Number 810M5535 - 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)