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Terminated

Stryker 7.5mm x 9.5mm Acorn Bur, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-30-75.

FDA Recall Z-1025-2008 · Posted 2008-04-22

Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeHBE
Date Initiated2008-01-10
Date Terminated2009-12-01
Product Quantity10,588 of all products

Reason for Recall

Lack of assurance of sterility.

Firm Action

Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.

Root Cause

Package design/selection

Distribution Pattern

Worldwide Distribution - USA, Australia, Brazil, Canada, England, France, Germany, Hong Kong, India, Italy, Japan, Mexico, the Netherlands, New Zealand, Portugal, Saudi Arabia, Poland, Romania, South Africa, Spain, Sweden, Switzerland and United Arab Emirates.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032303STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEMStryker Instruments · 2004-01-16

Official Source

View FDA Recall →

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

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