Agency classClass IIOur severity:High FDA (Devices)·Z-2786-2016·Announced 2016-09-21

Howmedica Recalls AccuLIF PL Spinal Cages Due to Height Reduction

Howmedica Osteonics Corp. is recalling AccuLIF PL spinal cages because some implants have shown a reduction in height greater than 1 mm after surgery.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect (height reduction) that poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Howmedica Osteonics Corp. is recalling AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cages. These medical devices are indicated for intervertebral body fusion in patients with degenerative disc disease or degenerative scoliosis. The recall covers specific catalog and lot numbers distributed nationwide.

The recall is being conducted because product inquiries have confirmed that some AccuLIF PL implants have experienced a reduction in height greater than 1 mm following surgery. Since Stryker acquired the product in March 2014, the occurrence rate for this issue is approximately 0.47%, with a slight upward trend noted since September 2015.

Patients who have received these specific implants should contact their healthcare provider to discuss the findings and determine if any follow-up care is necessary.

The recalled product

Product: AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an…
Manufacturer: Howmedica Osteonics Corp.
Category: Medical Device — Spinal Implant
Hazard: structural-defect
implant-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Catalog #400006 Lot #'s 01141604
01141609
01141614
01231506
01231507
01271513
01271514
02021508
02021509
02021510
02021511
03271306
04291403
04291404
04301513
04301514
04301515
04301516
06251504
06291506

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Howmedica Osteonics Corp.

See all →

Severe
Howmedica Recalls Scorpio Patella Implants Due to Polyethylene Wear Risk
FDA (Devices) · 2026-09-23
High
Howmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
FDA (Devices) · 2026-09-23
Severe
Howmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
FDA (Devices) · 2026-09-23
High
Howmedica Recalls Orthopaedic Implant Components Due to Material Aging
FDA (Devices) · 2026-09-23
High
Howmedica Recalls Scorpio Receded Metal Backed Patella Implants
FDA (Devices) · 2026-09-23

Same hazard · structural defect