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Recall Observatory FDA recall evidence

Device product

Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512

Z-2535-2016

July 14, 2016

Class II

Product summary

Firm
Straumann Manufacturing, Inc.
Event
Event 74799
Status
Terminated
Classification
Class II
Quantity
33 pieces
Official record key
device-enforcement:Z-2535-2016

Official wording

Reason: Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration

Code information: Lot Number: LT123

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration