Reliance LITe Nerve Hook Bayoneted — Class II medical device recall Z-0657-2019
Terminated recall by Howmedica Osteonics Corp., reported 2018-12-26. Instead of having a spherical diameter, the probe was observed to have 2 radii and a flat surface. Additionall
| Recall number | Z-0657-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Allendale, NJ, United States |
| Recall initiated | 2018-11-26 |
| Classified | 2018-12-20 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2020-05-26 |
| Countries outside the US | AU, CA, ES, FR, IT, NL, PL |
| Quantity | 39 |
| Lot numbers | 17E168, 183432, 183433, 183434 |
| Model numbers | 48066103 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0657-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.