Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires. Packaged in 19 packages of 100 and 6 packages of 10.
FDA device recall Z-2963-2011 · posted 2011-08-09 · Terminated
Recall details
- Recalling firm
- Highland Metals
- Reason for recall
- Heat Activated Niti, Natural, Upper, .019 x 25" Arch wires mixed with size 021x0.25" Arch Wires.
- Action taken
- Highland Metals, Inc. notified their affected customers by e-mail and followed with an "Important Alert" letter dated July 12, 2011. The letters informed customers of the mix up of wires. Customers were asked to contact Highland Metals at 800-368-6484 to schedule a call tag to return any remaining product. Upon receipt credit will be issued. For additional information contact Highland Metals at (800) 448-7971 or (408) 271-2955.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- D
- Quantity affected
- 10 packages of 100
- Distribution
- Worldwide Distribution; Nationwide (USA) distribution including the states of NV, CT, and FL; and the countries of Australia and Turkey.
- Date initiated
- 2011-07-12
- Date posted
- 2011-08-09
- Date terminated
- 2011-09-14
- Location
- San Jose, CA
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