Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 12, 2017
EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01
Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Exactech, Inc. recalled EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01 - a moderate-severity action.
EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01 was recalled by Exactech, Inc. in July 12, 2017. Reason: Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid…. Check the official notice for the remedy. Verify recall #Z-2665-2017 with the FDA Devices before acting.
The recall
Exactech, Inc. issued this moderate-severity FDA Devices recall-Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid….
- Moderate
- severity level
- 928 units
- affected scope
- Class II
- classification
- July 12, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2665-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2665-2017) was formally reported on July 12, 2017, with the manufacturer initiating the action on May 25, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Exactech, Inc. is listed as the recalling firm, operating out of Gainesville, FL. Federal records list the affected scope as 928.
The documented reason for this recall is: Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may resu… Distribution data in the federal record shows the product reached: AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, Hawaii and Puerto Rico Australia, Austria, Brazil, Canada, China, France, Germany, Greece, In…. 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 - 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 - 40,422 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
928
Related Recalls
6
0 from same agency
Product description
EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01
Reason for recall
Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2665-2017 |
| Date reported | July 12, 2017 |
| Date initiated | May 25, 2017 |
| Recalling firm | Exactech, Inc. |
| Firm location | Gainesville, FL |
| Affected scope | 928 |
| Distribution | AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, Hawaii and Puerto Rico Australia, Austria, Brazil, Canada, China, France, Germany, Greece, India, Italy, Korea, L… |
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-2665-2017) 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? ▼
EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01. Recalled by Exactech, Inc.. Units affected: 928.
Why was this product recalled? ▼
Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 12, 2017. Severity: Moderate. Recall number: Z-2665-2017.
Where was the recalled product distributed? ▼
Distribution: AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, Hawaii and Puerto Rico Australia, Austria, Brazil, Canada, China, France, Germany, Greece, India, Italy, Korea, Luxembourg, Singapore, South Africa, Spain, Sweden, Switzerland, The Netherlands and United Kingdom.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2665-2017) 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 July 12, 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.