Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 13, 2018
Restoris MCK Onlay Insert Extractor.
Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Mako Surgical Corporation recalled Restoris MCK Onlay Insert Extractor. - a moderate-severity action.
Restoris MCK Onlay Insert Extractor. was recalled by Mako Surgical Corporation in June 13, 2018. Reason: Possible hinge pin disassociation from the Mako Onlay Insert Extractor.. Check the official notice for the remedy. Verify recall #Z-2051-2018 with the FDA Devices before acting.
The recall
Mako Surgical Corporation issued this moderate-severity FDA Devices recall-Possible hinge pin disassociation from the Mako Onlay Insert Extractor..
- Moderate
- severity level
- 575 units
- affected scope
- Class II
- classification
- June 13, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2051-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2051-2018) was formally reported on June 13, 2018, with the manufacturer initiating the action on January 19, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Mako Surgical Corporation is listed as the recalling firm, operating out of Davie, FL. Federal records list the affected scope as 575 units total (400 US, 175 OUS).
The documented reason for this recall is: Possible hinge pin disassociation from the Mako Onlay Insert Extractor. Distribution data in the federal record shows the product reached: Distributed domestically to AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, WI. Distributed internationally to Australia, China, Italy, Netherlands, S…. 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
575 units total (400 US, 175 OUS)
Related Recalls
6
3 from same agency
Product description
Restoris MCK Onlay Insert Extractor.
Reason for recall
Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2051-2018 |
| Date reported | June 13, 2018 |
| Date initiated | January 19, 2018 |
| Recalling firm | Mako Surgical Corporation |
| Firm location | Davie, FL |
| Affected scope | 575 units total (400 US, 175 OUS) |
| Distribution | Distributed domestically to AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, WI. Distributed internationally to Australia, China, Italy, Netherlands, Singapore, South Afri… |
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-2051-2018) 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? ▼
Restoris MCK Onlay Insert Extractor.. Recalled by Mako Surgical Corporation. Units affected: 575 units total (400 US, 175 OUS).
Why was this product recalled? ▼
Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 13, 2018. Severity: Moderate. Recall number: Z-2051-2018.
Where was the recalled product distributed? ▼
Distribution: Distributed domestically to AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, WI. Distributed internationally to Australia, China, Italy, Netherlands, Singapore, South Africa, Taiwan, Turkey, United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2051-2018) 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 June 13, 2018. 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.