Food, drugs, devices › Howmedica Osteonics Corp.
Device recall: AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a
FDA enforcement event 79147 is a device recall by Howmedica Osteonics Corp. of Allendale, NJ, initiated 8 Sep 2017 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 31 Jul 2018. Initiation: voluntary: firm initiated. Howmedica Osteonics Corp. has 48 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Howmedica Osteonics Corp., Allendale, NJ.
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."
Distribution
"Nationally"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0810-2018 | 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… | 130 | Class II | Terminated | 7 Mar 2018 |
Context
Other enforcement events for Howmedica Osteonics Corp.
All 48 events for Howmedica Osteonics Corp.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationally"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 31 Jul 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.