Reported Feb 28, 2018 · Terminated
Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide…
Innovasis, 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: Innovasis, Inc · 614 E 3900 S · Salt Lake City, UT · 84107-1902
Is this the product you have?
- Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar
- and sacral spine—
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published E28540Lot Number: 1101 and Catalog/ , E28545 with — Lot Number: 1201. Each of these parts is engraved with part number and — lot number. - Amount recalled
- 1,010 parts
Why it was recalled
Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.
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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