—#169205

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.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot #s 183432, 183433, 183434, 17E168

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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)..

Recalling firm

Firm: Howmedica Osteonics Corp.
Address: 2 Pearl Ct, Allendale, New Jersey 07401-1611

Distribution

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

Timeline

Recall initiated: 2018-11-26
Terminated: 2020-05-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #169205. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.