Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1182-2024 — IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm 132-10-90-250 / IdentiTi ALIF SA Graft Bolt, 09 x 25 m

U.S. FDA — Device Enforcement · United States · 2024-01-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1182-2024
Date of alert: 2024-01-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Alphatec Spine, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00190376299716

Reported risk: Due to reports of intraoperative graft bolt implantation breakages.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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