FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: 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.
- Recall number
- Z-1052-2013
- Recalling firm
- Stryker 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.
- Status
- Terminated
- Initiated
- 2012-11-08
- Posted
- 2013-04-12
- Terminated
- 2021-01-11
- Reason
- 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
- 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
- 7868 units
- Distribution
- USA Nationwide Distribution
- Lot, serial or model codes
- Catalog No: TR7100-L and TR7100-R Lot Code: All
- 510(k) numbers
- ["K110533","K122053"]
- PMA numbers
- not on file
- Product code
- MBH
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28