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Terminated

ProVision Hytrel Elastomer Hood; product 5431-05-000.

FDA Recall Z-1040-03 · Posted 2003-07-23

Recalling FirmDepuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeFYA
Date Initiated2003-06-27
Date Terminated2004-02-04

Reason for Recall

Lack of assurance of sterility, due to the possibility of an incomplete package seal.

Firm Action

An Urgent Recall Notice was sent to customers on June 27, 2003 via federal express. Customers were instructed to locate all affected inventory and to immediately return it to Depuy.

Root Cause

Other

Distribution Pattern

United States, Australia, Canada, Chile, England, India, Japan, Malaysia, Singapore, South Africa, Taiwan and United Kingdom

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K972832PROVISION SURGICAL HELMET SYSTEMDepuy, Inc. · 1997-10-21

Official Source

View FDA Recall →

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

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