Agency classClass IIOur severity:High FDA (Devices)·Z-2787-2016·Announced 2016-09-21

Howmedica Recalls AccuLIF PL Cages Due to Height Reduction

Howmedica Osteonics Corp. is recalling AccuLIF PL 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 is classified as FDA Class II, and the hazard involves a structural defect in a spinal implant that could lead to injury, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Howmedica Osteonics Corp. is recalling AccuLIF PL 8-12mm 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 is due to reports of post-operative reduction of cage height greater than 1 mm.

Since Stryker acquired the AccuLIF product in March 2014, product inquiries have confirmed this height reduction issue. The current occurrence rate for reported post-operative reduction of cage height is approximately 0.47%, with a slight upward trend noted since September 2015. The affected units are distributed nationwide and include specific catalog and lot numbers listed in the recall documentation.

Healthcare providers and patients should contact Howmedica Osteonics Corp. for further instructions regarding the recall and potential replacement or repair of the affected devices.

The recalled product

Product: AccuLIF PL 8-12mm 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 #400008 Lot #'s 01141602
01141607
01141610
01141612
01141617
02021601
02021603
02021605
02161503. 02161504
02161506
02161507
02161508
02161509
02161510
02161511
02161512
02161513
02161514
02161515
03061309

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.

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Same hazard · structural defect