Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 6, 2016
Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: ES310-R; Used to dissect bone in surgical applications.
Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use.
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution recalled Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Sa… - a moderate-severity action.
Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Sa… was recalled by Medtronic Sofamor Danek Usa, Inc - Dallas Distribution in July 6, 2016. Reason: Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for l…. Check the official notice for the remedy. Verify recall #Z-2085-2016 with the FDA Devices before acting.
The recall
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution issued this moderate-severity FDA Devices recall-Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for l….
- Moderate
- severity level
- 368 units
- affected scope
- Class II
- classification
- July 6, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2085-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2085-2016) was formally reported on July 6, 2016, with the manufacturer initiating the action on May 13, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Sofamor Danek Usa, Inc - Dallas Distribution is listed as the recalling firm, operating out of Haltom City, TX. Federal records list the affected scope as 368 devices.
The documented reason for this recall is: Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use. Distribution data in the federal record shows the product reached: Worldwide Distribution-Including the states of AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, MA, MD, NC, NH, NY, SC, TN, TX, and UT.. 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
368 devices
Related Recalls
6
3 from same agency
Product description
Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: ES310-R; Used to dissect bone in surgical applications.
Reason for recall
Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2085-2016 |
| Date reported | July 6, 2016 |
| Date initiated | May 13, 2016 |
| Recalling firm | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution |
| Firm location | Haltom City, TX |
| Affected scope | 368 devices |
| Distribution | Worldwide Distribution-Including the states of AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, MA, MD, NC, NH, NY, SC, TN, TX, and UT. |
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-2085-2016) 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? ▼
Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: ES310-R; Used to dissect bone in surgical applications.. Recalled by Medtronic Sofamor Danek Usa, Inc - Dallas Distribution. Units affected: 368 devices.
Why was this product recalled? ▼
Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 6, 2016. Severity: Moderate. Recall number: Z-2085-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-Including the states of AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, MA, MD, NC, NH, NY, SC, TN, TX, and UT..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2085-2016) 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 July 6, 2016. 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.