Reported Jun 21, 2023 · Ongoing
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803,…
New Standard Device 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: New Standard Device Inc · 4848 Research Dr · San Antonio, TX · 78240-5005
Is this the product you have?
- 'n'-Hole Post which is a component of the Revolution External
- Fixation System Catalog Numbers
100801100802100803100804100805
- Lot codes and dates
- Catalog Numbers / Lot Numbers100801 / A29318R 100802 / A29318S 100803 / A29318T 100804 /
- A29318U 100805 / A29318V UDI CodesNot provided/None
- Amount recalled
- 222 units
Where it was sold
Why it was recalled
The threads on posts stripping out when tensioned during application process.
This product could cause temporary or reversible health problems — stop using it.
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