FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0657-2019
- 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.
- Status
- Terminated
- Initiated
- 2018-11-26
- Posted
- not on file
- Terminated
- 2020-05-26
- 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.
- Lot, serial or model codes
- Lot #s 183432, 183433, 183434, 17E168
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3004024955
- Firm city
- Allendale
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28