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

Recall Z-2238-2015 — Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-120; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)

U.S. FDA — Device Enforcement · United States · 2015-02-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2238-2015
Date of alert
2015-02-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
EXP Pharmaceutical Services Corp
Product category
device
Product type
Devices
Reported risk: EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
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.