Z-0657-2019Class II

Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a...

Name: Z-0657-2019 Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a...
Creator: Howmedica Osteonics Corp.
Published: 2018-11-26
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2018-11-26 / Terminated

FDA source

Howmedica Osteonics Corp. began a recall of 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... on 2018-11-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0657-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-26
Posted: 2018-12-21
Terminated: 2020-05-26
Recalling firm: Howmedica Osteonics Corp
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.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
FDA 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: [email protected]. For questions contact Manager-Regulatory Compliance & Quality System at 866-45-SPINE (77463)..
Quantity in commerce: 39
Distribution: Worldwide distribution: US Distribution to the state of: PA and countries of:: Australia, Canada, France, Italy, Netherlands, Poland, and Spain.
Product codes and lots: Lot #s 183432, 183433, 183434, 17E168

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0657-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0657-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-20

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)