AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage — Class II medical device recall Z-2788-2016
Terminated recall by Howmedica Osteonics Corp., reported 2016-09-21. Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to
| Recall number | Z-2788-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Allendale, NJ, United States |
| Recall initiated | 2016-07-26 |
| Classified | 2016-09-12 |
| Reported by FDA | 2016-09-21 |
| Terminated | 2018-03-12 |
| Lot numbers | 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, 12151517 |
| Model numbers | 400010 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2788-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.