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

Recall Z-1631-2013 — - Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm Dia. x 9.5mm Length Ref. 5130-30-75 Lot 122665 - Cannulated Drill Bit, for 3.0mm Cannulated Screws, 1.2mm Cannulation, Quick Coupling 2.0mm x 150mm Ref. 310.221 Lot 122289 - Drill Bit, For Modular Hand System

U.S. FDA — Device Enforcement · United States · 2013-05-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1631-2013
Date of alert: 2013-05-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Surgical Instrument Service And Savings, Inc.
Product category: device
Product type: Devices

Reported risk: The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

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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