Recall Z-0657-2019 · LXH Orthopedic Manual Surgical Instrument

Howmedica Osteonics Corp.

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.

Date	Nov 26, 2018
Status	Terminated
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.
Root cause	Under Investigation by 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: Spine-RegulatoryAction@stryker.com. For questions contact Manager-Regulatory Compliance & Quality System at 866-45-SPINE (77463)..
Quantity	39
Distribution	Worldwide distribution: US Distribution to the state of: PA and countries of:: Australia, Canada, France, Italy, Netherlands, Poland, and Spain.
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.