Reported Jun 10, 2020 · Terminated
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X40MM, Item Number 810M4540 - Product Usage: are…
Zimmer Biomet, 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: Zimmer Biomet, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X40MM
- Item Number 810M4540 - Product Usageare non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated for skeletally mature patients and for adolescence patients
- Lot codes and dates
- UDI(01)00887868324208
- Lot NumbersC20B0006 SBM108401 SBM118983 SBM121852 SBM122267
- Amount recalled
- 3235 total
This recall covers 25 products
The agency filed one notice per product. You are reading one of them; the other 24 are below.
12 more are in the archive.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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