Z-0810-2018Class II

AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed...

Name: Z-0810-2018 AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed...
Creator: Howmedica Osteonics Corp.
Published: 2017-09-08
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2017-09-08 / Terminated

FDA source

Howmedica Osteonics Corp. began a recall of 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... on 2017-09-08. FDA classified it as Class II and gives the reason 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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0810-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-08
Posted: 2018-03-01
Terminated: 2018-07-31
Recalling firm: Howmedica Osteonics Corp
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.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
FDA root cause: Under Investigation by firm
Action: A recall letter, dated August 25, 2017, titled "Product Recall Re: AccuLIFTL Insertion Handle" instructing customers to meet with the Stryker Representative issuing the letter, complete the requested form and return any affected product to this representative. Questions or concerns can be directed to Customer Service at 201-749-8699
Quantity in commerce: 130
Distribution: Nationally
Product codes and lots: Model# 800804 Lot numbers 160010 and 170003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0810-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0810-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)