Z-1052-2013Class I

ShapeMatch Cutting Guides

Name: Z-1052-2013 ShapeMatch Cutting Guides
Creator: Stryker Howmedica Osteonics Corp.
Published: 2012-11-08
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2012-11-08 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the... on 2012-11-08. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1052-2013
Classification: Class I
Status: Terminated
Initiated: 2012-11-08
Posted: 2013-04-12
Terminated: 2021-01-11
Recalling firm: Howmedica Osteonics Corp
Product: 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 code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
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.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker sent Product Correction Bulletins on 11/8/2012 dated 11/9/2012 and 11/19/2012 to all affected customers. Stryker sent an updated Urgent Medical Device Product Notification letters and Acknowledgement letters dated 1/24/2013 through 1/28/2013 to all affected customers via Fed Ex with return receipt: The letter identified the affect product, problem, potential hazards, risk mitigating factors and actions to be taken. For questions call 201-831-6878. Stryker issued press release on 4/10/2013.
Quantity in commerce: 7868 units
Distribution: USA Nationwide Distribution
Product codes and lots: Catalog No: TR7100-L and TR7100-R Lot Code: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1052-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1052-2013	Class I	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-12

Product code MBH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)