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Terminated

Stryker Instruments 2.1 mm Cross-Cut Fissure Bur, carbide extended, sterile; REF 2296-101-621.

FDA Recall Z-0263-2010 · Posted 2009-11-16

Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeDZI
Date Initiated2009-10-05
Date Terminated2009-11-30
Product Quantity93

Reason for Recall

The cross-cuts are missing on the device, which will result in poor cutting and overheating and/or smoking of the device.

Firm Action

Consignees were notified by letter dated 10/5/09 and requested to return the devices to Stryker. The international account was notified by email.

Root Cause

Vendor change control

Distribution Pattern

USA (California, Georgia, Louisiana, Ohio, Wisconsin) and Brazil.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040369STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEMStryker Instruments · 2004-04-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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