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Recall Observatory FDA recall evidence

Device product

Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving nerve retraction. The bend at the proximal tip of the ring the discectomy, as well as during the insertion of an IBD during a conventional TLIF procedure.

Z-0657-2019

November 26, 2018

Class II

Product summary

Firm
Howmedica Osteonics Corp.
Event
Event 81645
Status
Terminated
Classification
Class II
Quantity
39
Official record key
device-enforcement:Z-0657-2019

Official wording

Reason: Instead of having a spherical diameter, the probe was observed to have 2 radii and a flat surface. Additionally, upon further investigation, it was observed that some parts exhibited an edge on the intersection between the radius and the diameter of the probe.

Code information: Lot #s 183432, 183433, 183434, 17E168

Distribution pattern: Worldwide distribution: US Distribution to the state of: PA and countries of:: Australia, Canada, France, Italy, Netherlands, Poland, and Spain.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Instead of having a spherical diameter, the probe was observed to have 2 radii and a flat surface. Additionally, upon further investigation, it was observed that some parts exhibited an edge on the intersection between the radius and the diameter of the probe.