XIA 3 System - Serrato - Polyaxial Screw (2019-06-18)

Starting date:

June 18, 2019

Posting date:

July 5, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70365

Last updated: 2019-07-05

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  Reason
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  Affected products

Affected Produtcs

XIA 3 System - Serrato - Polyaxial Screw

Reason

Stryker identified a serrato screw of discrepant length during inspection. Subsequently a product manufacturing mix up/swap between lot # B90243 [9.5X100mm] and lot # B88751 [9.5X90mm]. Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length; lot B90243 100mm screws were manufactured with a 90mm length instead of the required 100mm length.

Affected products