FDA Enforcement
Class II
Terminated
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: Z-0657-2019
·
Reported December 26, 2018
Enforcement
- Recall Number
- Z-0657-2019
- Event ID
- 81645
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Howmedica Osteonics Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 26, 2018
- Initiation Date
- November 26, 2018
- Classification Date
- December 20, 2018
- Termination Date
- May 26, 2020
- Address
- 2 Pearl Ct, Allendale, NJ, 07401-1611, United States
Description
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.
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.
Code Info
Lot #s 183432, 183433, 183434, 17E168
Distribution
Worldwide distribution: US Distribution to the state of: PA and countries of:: Australia, Canada, France, Italy, Netherlands, Poland, and Spain.
Quantity
39