Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 17, 2019
iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.
The kits were prepared with incorrect patient ID labels and may contain incorrect components.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Conformis, Inc. recalled iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102… - a moderate-severity action.
iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102… was recalled by Conformis, Inc. in April 17, 2019. Reason: The kits were prepared with incorrect patient ID labels and may contain incorrect components.. Check the official notice for the remedy. Verify recall #Z-1108-2019 with the FDA Devices before acting.
The recall
Conformis, Inc. issued this moderate-severity FDA Devices recall-The kits were prepared with incorrect patient ID labels and may contain incorrect components..
- Moderate
- severity level
- 2 units
- affected scope
- Class II
- classification
- April 17, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1108-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1108-2019) was formally reported on April 17, 2019, with the manufacturer initiating the action on December 3, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Conformis, Inc. is listed as the recalling firm, operating out of Billerica, MA. Federal records list the affected scope as 2.
The documented reason for this recall is: The kits were prepared with incorrect patient ID labels and may contain incorrect components. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary.. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2
Related Recalls
6
3 from same agency
Product description
iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.
Reason for recall
The kits were prepared with incorrect patient ID labels and may contain incorrect components.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1108-2019 |
| Date reported | April 17, 2019 |
| Date initiated | December 3, 2018 |
| Recalling firm | Conformis, Inc. |
| Firm location | Billerica, MA |
| Affected scope | 2 |
| Distribution | Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary. |
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-1108-2019) 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? ▼
iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.. Recalled by Conformis, Inc.. Units affected: 2.
Why was this product recalled? ▼
The kits were prepared with incorrect patient ID labels and may contain incorrect components.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 17, 2019. Severity: Moderate. Recall number: Z-1108-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1108-2019) 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.
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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 17, 2019. 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.