Stryker Imaging 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Stryker Imaging
Lot Codes / Batch Numbers
All accounts that have OrthoPad and are signed up for Guardian Services backup.
Products Sold
All accounts that have OrthoPad and are signed up for Guardian Services backup.
Stryker Imaging is recalling Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with Part Numbers due to Guardian Services data backup does not contain 100% data for all OrthoPad customers on a daily basis.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Guardian Services data backup does not contain 100% data for all OrthoPad customers on a daily basis.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026