Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 25, 2020
D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing t…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
TeDan Surgical Innovations LLC recalled D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction… - a moderate-severity action.
D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction… was recalled by TeDan Surgical Innovations LLC in March 25, 2020. Reason: The items identified for recall are labeled as sterile. However, the manufacturer has found that product pack…. Check the official notice for the remedy. Verify recall #Z-1503-2020 with the FDA Devices before acting.
The recall
TeDan Surgical Innovations LLC issued this moderate-severity FDA Devices recall-The items identified for recall are labeled as sterile. However, the manufacturer has found that product pack….
- Moderate
- severity level
- Class II
- classification
- March 25, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1503-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1503-2020) was formally reported on March 25, 2020, with the manufacturer initiating the action on February 18, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. TeDan Surgical Innovations LLC is listed as the recalling firm, operating out of Sugar Land, TX. Federal records list the affected scope as 49 boxes (245 individual screws).
The documented reason for this recall is: The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. Th… Distribution data in the federal record shows the product reached: Worldwide.. 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
49 boxes (245 individual screws)
Related Recalls
6
3 from same agency
Product description
D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
Reason for recall
The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1503-2020 |
| Date reported | March 25, 2020 |
| Date initiated | February 18, 2019 |
| Recalling firm | TeDan Surgical Innovations LLC |
| Firm location | Sugar Land, TX |
| Affected scope | 49 boxes (245 individual screws) |
| Distribution | Worldwide. |
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-1503-2020) 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? ▼
D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.. Recalled by TeDan Surgical Innovations LLC. Units affected: 49 boxes (245 individual screws).
Why was this product recalled? ▼
The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 25, 2020. Severity: Moderate. Recall number: Z-1503-2020.
Where was the recalled product distributed? ▼
Distribution: Worldwide..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1503-2020) 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 March 25, 2020. 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.