Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 7, 2017
The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants are provided in sterile packages. The Acumed Anatomic Radial Head Slide-Loc System consists of modular heads and stems with accessories for anatomical replacement of the proximal portion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and ca
The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market. The firm received product compla…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Acumed LLC recalled The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with ort… - a moderate-severity action.
The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with ort… was recalled by Acumed LLC in June 7, 2017. Reason: The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System bas…. Check the official notice for the remedy. Verify recall #Z-2197-2017 with the FDA Devices before acting.
The recall
Acumed LLC issued this moderate-severity FDA Devices recall-The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System bas….
- Moderate
- severity level
- Class II
- classification
- June 7, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2197-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2197-2017) was formally reported on June 7, 2017, with the manufacturer initiating the action on April 20, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Acumed LLC is listed as the recalling firm, operating out of Hillsboro, OR. Federal records list the affected scope as 13076 parts total (8373 units of parts/instruments and 4703 units of implantable parts).
The documented reason for this recall is: The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market. The firm received product complaints regarding instrumentation performan… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of AK, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA and in Puerto Rico.. 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
13076 parts total (8373 units of parts/instruments and 4703 units of implantable parts)
Related Recalls
6
3 from same agency
Product description
The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants are provided in sterile packages. The Acumed Anatomic Radial Head Slide-Loc System consists of modular heads and stems with accessories for anatomical replacement of the proximal portion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitellum of the distal humerus. The modular heads and stems are single use implantable devices. Each Acumed Slide-Loc Anatomic Radial Head System Set consists of 76 parts/instruments.
Reason for recall
The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market. The firm received product complaints regarding instrumentation performance, trial product design, and implant dissociations.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2197-2017 |
| Date reported | June 7, 2017 |
| Date initiated | April 20, 2017 |
| Recalling firm | Acumed LLC |
| Firm location | Hillsboro, OR |
| Affected scope | 13076 parts total (8373 units of parts/instruments and 4703 units of implantable parts) |
| Distribution | US Nationwide distribution in the states of AK, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA and in Puerto Rico. |
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-2197-2017) 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? ▼
The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants are provided in sterile packages. The Acumed Anatomic Radial Head Slide-Loc System consists of modular heads and stems with accessories for anatomical replacement of the proximal portion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitellum of the distal humerus. The modular heads and stems are single use implantable devices. Each Acumed Slide-Loc Anatomic Radial Head System Set consists of 76 parts/instruments.. Recalled by Acumed LLC. Units affected: 13076 parts total (8373 units of parts/instruments and 4703 units of implantable parts).
Why was this product recalled? ▼
The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market. The firm received product complaints regarding instrumentation performance, trial product design, and implant dissociations.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 7, 2017. Severity: Moderate. Recall number: Z-2197-2017.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of AK, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA and in Puerto Rico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2197-2017) 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 7, 2017. 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.