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

Recall Z-2530-2016 — Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile component used with the Perioscopy System, which is a medical device that features miniaturized digital video technology, and enables the healthcare professional to see magnified details of the tooth anatomy

U.S. FDA — Device Enforcement · United States · 2016-06-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2530-2016
Date of alert: 2016-06-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Danville Materials, Inc.
Product category: device
Product type: Devices

Reported risk: The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date. Danville Materials has become aware that validation data are not available to support the 3-year shelf-life/expiration dating claim.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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