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Terminated

Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with Part Numbers 0250-003-016, 0250-003-017 and 0250-003-018 (OrthoPad) Intended use of Guardian Services is to act as a medical data backup and disaster recovery plan.

FDA Recall Z-0160-2010 · Posted 2009-11-10

Recalling FirmStryker Imaging
Recall StatusTerminated
Product CodeLMB
Date Initiated2009-08-03
Date Terminated2010-01-26
Product Quantity85

Reason for Recall

Guardian Services data backup does not contain 100% data for all OrthoPad customers on a daily basis.

Firm Action

Firm notified consignees by an Urgent: Device Correction letter, dated 7/31/2009. The letter states the problem and that Stryker is upgrading its internal infrastructure to remediate the problem. The letter also states the firm's recommendations to reduce risk to patients. Stryker will not bill customers for the Guardian service until the problem is remediated and the firm notifies customers. If there are any questions, customers are to contact the firm at 972-410-7100.

Root Cause

Other

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

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

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