Reported Aug 19, 2020 · Terminated
Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded…
Anjon Holdings
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: Anjon Holdings · 4801 Dawin Rd · Jacksonville, FL · 32207-9512
Is this the product you have?
- Anjon Bremer Molded Crown. bone fixation fastener for spinal use
- REF number 100048 - Product UsageSmooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions
- Lot codes and dates
REF number 100048 Lot # 170240US customer Lot # 17016217016370164170165170229170240170247170260 and SM 42048. International customers
- Amount recalled
- 249 devices
Where it was sold
- Nationwide
- MI
Why it was recalled
High rate of galling of one threaded component.
This product could cause temporary or reversible health problems — stop using it.
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