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.
FDA Recall Z-0657-2019 · Posted None
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Recalling FirmHowmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLXH
Date Initiated2018-11-26
Date Terminated2020-05-26
Product Quantity39
Reason for Recall
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.
Firm Action
The firm, Stryker, sent an "Urgent Medical Device Recall" letter dated 11/14/2018 to its customers on 11/26/2018. The letter described product, problem and actions to be taken. The customers were instructed to: Examine your inventory; Immediately quarantine the affected product; and complete customer response form to Stryker Spine at email: [email protected].
For questions contact Manager-Regulatory Compliance & Quality System at 866-45-SPINE (77463)..
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution: US Distribution to the state of: PA and countries of:: Australia, Canada, France, Italy, Netherlands, Poland, and Spain.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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