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Recall Observatory FDA recall evidence

Device product

aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00

Z-1675-2020

November 28, 2019

Class II

Product summary

Firm
AAP Implantate Ag
Event
Event 84716
Status
Terminated
Classification
Class II
Quantity
7 units
Official record key
device-enforcement:Z-1675-2020

Official wording

Reason: The company has become aware that the soft tissue retractor is not always removed during the sawing process. This can result in damage to the soft tissue retractor in which abrasion debris can develop and remain in vivo.

Code information: Lot Numbers: I012, I025, I028

Distribution pattern: Worldwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The company has become aware that the soft tissue retractor is not always removed during the sawing process. This can result in damage to the soft tissue retractor in which abrasion debris can develop and remain in vivo.