Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 3, 2014
Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet speci…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Materialise USA LLC recalled Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to… - a moderate-severity action.
Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to… was recalled by Materialise USA LLC in December 3, 2014. Reason: The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) …. Check the official notice for the remedy. Verify recall #Z-0418-2015 with the FDA Devices before acting.
The recall
Materialise USA LLC issued this moderate-severity FDA Devices recall-The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) ….
- Moderate
- severity level
- 1 units
- affected scope
- Class II
- classification
- December 3, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0418-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0418-2015) was formally reported on December 3, 2014, with the manufacturer initiating the action on October 16, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Materialise USA LLC is listed as the recalling firm, operating out of Plymouth, MI. Federal records list the affected scope as 1.
The documented reason for this recall is: The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and on… Distribution data in the federal record shows the product reached: Nationwide Distribution to MN only. 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
1
Related Recalls
6
3 from same agency
Product description
Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
Reason for recall
The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0418-2015 |
| Date reported | December 3, 2014 |
| Date initiated | October 16, 2014 |
| Recalling firm | Materialise USA LLC |
| Firm location | Plymouth, MI |
| Affected scope | 1 |
| Distribution | Nationwide Distribution to MN only |
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-0418-2015) 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? ▼
Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.. Recalled by Materialise USA LLC. Units affected: 1.
Why was this product recalled? ▼
The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 3, 2014. Severity: Moderate. Recall number: Z-0418-2015.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution to MN only.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0418-2015) 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 December 3, 2014. 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.