Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported April 24, 2013
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.
With regards to ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become aware that there are potential issues associated with internal processes for plannin…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Stryker Howmedica Osteonics Corp. recalled ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended t… - a critical-severity action.
ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended t… was recalled by Stryker Howmedica Osteonics Corp. in April 24, 2013. Reason: With regards to ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become aware that ther…. Check the official notice for the remedy. Verify recall #Z-1052-2013 with the FDA Devices before acting.
The recall
Stryker Howmedica Osteonics Corp. issued this critical-severity FDA Devices recall-With regards to ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become aware that ther….
- Critical
- severity level
- 8K units
- affected scope
- Class I
- classification
- April 24, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1052-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1052-2013) was formally reported on April 24, 2013, with the manufacturer initiating the action on November 8, 2012. It is classified under Critical severity (Class I), with a current status of Terminated. Stryker Howmedica Osteonics Corp. is listed as the recalling firm, operating out of Mahwah, NJ. Federal records list the affected scope as 7868 units.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: USA Nationwide Distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
7868 units
Related Recalls
6
3 from same agency
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1052-2013 |
| Date reported | April 24, 2013 |
| Date initiated | November 8, 2012 |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Firm location | Mahwah, NJ |
| Affected scope | 7868 units |
| Distribution | USA Nationwide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1052-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Stryker Howmedica Osteonics Corp.. Units affected: 7868 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2013. Severity: Critical. Recall number: Z-1052-2013.
Where was the recalled product distributed? ▼
Distribution: USA Nationwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1052-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
· 2026-07-02
CPSC Moderate
Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…
· 2026-06-25
CPSC Moderate
Arizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by…
· 2026-06-18
FDA Devices Moderate
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used i…
GE Medical Systems Information Technologies Inc · 2026-06-03
FDA Devices Critical
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit…
Medline Industries, LP · 2026-06-03
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 24, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.