AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to… — Class II medical device recall Z-0810-2018
Terminated recall by Howmedica Osteonics Corp., reported 2018-03-07. When the lever of the Insertion Handle is in the "locked" position, the implant may be able to pivot rather th
| Recall number | Z-0810-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Allendale, NJ, United States |
| Recall initiated | 2017-09-08 |
| Classified | 2018-03-01 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2018-07-31 |
| Quantity | 130 |
| Lot numbers | 160010, 170003 |
| Model numbers | 800804 |
Product
AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to insert the implant into the disc space with a fixed engagement between the two components to permit a controlled positioning of the implant in the anterior portion of the intervertebral space, and then through activation of the rotational pivot between the Handle and implant for final placement of the crescent-shaped cage across the anterior portion of the disc space. The AccuLIF TL Cages are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DOD) at one level or two contiguous levels from L2 to S1.
Reason for recall
When the lever of the Insertion Handle is in the "locked" position, the implant may be able to pivot rather than maintaining a rigid connection.
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-0810-2018. 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.