ModerateClass IITerminated

FDA Devices recall · Reported December 27, 2017

The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on December 27, 2017. Severity: Moderate. Recall number: Z-0266-2018.

Q: 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.

Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1%. For this reason, we stress the importance of using the 3.5 Nm tor…

Recall #: Z-0266-2018
Affected scope: 12,768 units
Initiated: October 24, 2017

Compiled from official public sources by the publisher. · Updated September 2026

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Medacta Usa Inc recalled The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Pr… - a moderate-severity action.

The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Pr… was recalled by Medacta Usa Inc in December 27, 2017. Reason: Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1…. Check the official notice for the remedy. Verify recall #Z-0266-2018 with the FDA Devices before acting.

The recall

Medacta Usa Inc issued this moderate-severity FDA Devices recall-Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1….

Moderate
severity level: 13K units
affected scope: Class II
classification: December 27, 2017
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0266-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF

Reason for recall

Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1%. For this reason, we stress the importance of using the 3.5 Nm torque limiting driver if the screw is used, as directed in our surgical techniques.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0266-2018
Date reported	December 27, 2017
Date initiated	October 24, 2017
Recalling firm	Medacta Usa Inc
Firm location	Memphis, TN
Affected scope	12,768 units
Distribution	nationwide

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

12,768 units units affected - limited or regional distribution scale.

Regional (<10K units) -

Multi-state (10K – 100K units) ✓ This recall

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0266-2018) 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.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on December 27, 2017. Severity: Moderate. Recall number: Z-0266-2018.

Where was the recalled product distributed? ▼

Distribution: nationwide.

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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported December 27, 2017. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026