—#161444

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.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Model# 800804 Lot numbers 160010 and 170003

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Howmedica Osteonics Corp.
Address: 2 Pearl Ct, Allendale, New Jersey 07401-1611

Distribution

Distribution pattern: Nationally

Timeline

Recall initiated: 2017-09-08
Terminated: 2018-07-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161444. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.