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

Recall Z-1976-2013 — Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.

U.S. FDA — Device Enforcement · United States · 2013-05-30 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1976-2013
Date of alert: 2013-05-30
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Stryker Spine
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 48551044

Reported risk: Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.

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.

Recall Z-1976-2013 — Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.

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