Z-2788-2016Class II

AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for...

Name: Z-2788-2016 AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for...
Creator: Howmedica Osteonics Corp.
Published: 2016-07-26
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2016-07-26 / Terminated

FDA source

Howmedica Osteonics Corp. began a recall of AccuLIF PL 10-16mm 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... on 2016-07-26. FDA classified it as Class II and gives the reason as "Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The current occurrence rate for reported...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2788-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-26
Posted: 2016-09-12
Terminated: 2018-03-12
Recalling firm: Howmedica Osteonics Corp
Product: AccuLIF PL 10-16mm 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 adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the AccuLIF PL Cages can be used as in adjunct to fusion in patients diagnosed with degenerative scoliosis. The AccuLIF Pl Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF PL Cages are to be used with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The current occurrence rate for reported post-operative reduction of cage height (> 1mm) of AccuLIF PL Expandable Cages is approximately 0.47% and has demonstrated a slight upward trend since September 2015.
FDA root cause: Unknown/Undetermined by firm
Action: Stryker Spine sent an "Urgent Recall Letter and Product Accountability Form" dated July 26, 2016 to all affected customers. For patients who have had an AccuLIF Posterior Lumbar (PL) Expandable Interbody implant, Stryker Spine is recommending routine clinical and radiographic post-operated evaluation. Should the patient report any change in or develop near-onset symptoms, more urgent clinical and radiographic evaluation should be completed. Customers with questions should call 201-749-8389 or 201-749-8346.
Distribution: NationwideDistribution
Product codes and lots: Catalog #400010 Lot #'s 01021403, 01121508, 01121509, 01271515, 01271516, 02021512, 02021513, 02021514, 02021515, 02021602, 03221310, 04141508, 04141509, 04141510, 04141511, 04141512, 04251312, 06101405, 06101406, 06101407, 06251311, 07011406, 07201510, 07201511, 07201512, 08141303, 08141313, 09251504, 09281512, 10081301, 10081302, 10201502, 10201503, 10301504, 11121514, 11121518, 11121521, 12151511 and 12151517

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2788-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2786-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-12
Z-2787-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-12
Z-2788-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-12

Product code MAX

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)