Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 28, 2012
"***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2009-02***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.
Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the S8585, 8.5MM SENTINEL Can…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Linvatec Corp. dba ConMed Linvatec recalled "***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CO… - a moderate-severity action.
"***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CO… was recalled by Linvatec Corp. dba ConMed Linvatec in November 28, 2012. Reason: Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill…. Check the official notice for the remedy. Verify recall #Z-0384-2013 with the FDA Devices before acting.
The recall
Linvatec Corp. dba ConMed Linvatec issued this moderate-severity FDA Devices recall-Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill….
- Moderate
- severity level
- Class II
- classification
- November 28, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0384-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0384-2013) was formally reported on November 28, 2012, with the manufacturer initiating the action on April 10, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Linvatec Corp. dba ConMed Linvatec is listed as the recalling firm, operating out of Largo, FL. Federal records list the affected scope as 70 total.
The documented reason for this recall is: Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the S8585, 8.5MM SENTINEL Cannulated Drill Bit, lot number 322287. Re… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania.. 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
70 total
Related Recalls
6
3 from same agency
Product description
"***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2009-02***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.
Reason for recall
Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the S8585, 8.5MM SENTINEL Cannulated Drill Bit, lot number 322287. Recall was initiated due to the incorrect labeling on package.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0384-2013 |
| Date reported | November 28, 2012 |
| Date initiated | April 10, 2012 |
| Recalling firm | Linvatec Corp. dba ConMed Linvatec |
| Firm location | Largo, FL |
| Affected scope | 70 total |
| Distribution | Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania. |
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-0384-2013) 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? ▼
"***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2009-02***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.. Recalled by Linvatec Corp. dba ConMed Linvatec. Units affected: 70 total.
Why was this product recalled? ▼
Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the S8585, 8.5MM SENTINEL Cannulated Drill Bit, lot number 322287. Recall was initiated due to the incorrect labeling on package.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 28, 2012. Severity: Moderate. Recall number: Z-0384-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0384-2013) 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 November 28, 2012. 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.