Stryker Howmedica Osteonics Corp.: Medical Device Recall in 2013 - (Recall #: Z-1052-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting.

Product Classification:

Class I

Date Initiated: November 8, 2012

Date Posted: April 24, 2013

Recall Number: Z-1052-2013

Event ID: 64308

Reason for Recall:

With regards to ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become aware that there are potential issues associated with internal processes for planning cases and producing ShapeMatch Cutting Guides.

Status: Terminated

Product Quantity: 7868 units

Code Information:

Catalog No: TR7100-L and TR7100-R Lot Code: All

Distribution Pattern:

USA Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated