Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 26, 2012
Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Screws are intended for the distraction in the anterior approach to the cervical spine. Sterile XL Screws are intended for the fixation of the blade to the vertebral body to prohibit drifting in the extreme lateral approac
This letter is to notify you that several of our sterile screw products are being voluntarily recalled. Product sterility may be compromised due to a mechanical failure of the pro…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Tedan Surgical Innovations Llc recalled Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3CO… - a moderate-severity action.
Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3CO… was recalled by Tedan Surgical Innovations Llc in September 26, 2012. Reason: This letter is to notify you that several of our sterile screw products are being voluntarily recalled. Produ…. Check the official notice for the remedy. Verify recall #Z-2385-2012 with the FDA Devices before acting.
The recall
Tedan Surgical Innovations Llc issued this moderate-severity FDA Devices recall-This letter is to notify you that several of our sterile screw products are being voluntarily recalled. Produ….
- Moderate
- severity level
- Class II
- classification
- September 26, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2385-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2385-2012) was formally reported on September 26, 2012, with the manufacturer initiating the action on June 11, 2012. 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 12,065 Sterile Distraction Screws (2413 boxes); 384 Sterile XL Screws (128 boxes) in distribution.
The documented reason for this recall is: This letter is to notify you that several of our sterile screw products are being voluntarily recalled. Product sterility may be compromised due to a mechanical failure of the protective packaging tube. Tube end plugs … Distribution data in the federal record shows the product reached: Worldwide distribution: USA (nationwide) and countries of : Australia and Taiwan.. 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
12,065 Sterile Distraction Screws (2413 boxes); 384 Sterile XL Screws (128 boxes) in distribution
Related Recalls
6
3 from same agency
Product description
Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Screws are intended for the distraction in the anterior approach to the cervical spine. Sterile XL Screws are intended for the fixation of the blade to the vertebral body to prohibit drifting in the extreme lateral approach to the lumbar spine.
Reason for recall
This letter is to notify you that several of our sterile screw products are being voluntarily recalled. Product sterility may be compromised due to a mechanical failure of the protective packaging tube. Tube end plugs may dislodge creating the potential for the screw to come out of the protective tube and then the sharp end of the screw pierce the outer sterile barrier pouch.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2385-2012 |
| Date reported | September 26, 2012 |
| Date initiated | June 11, 2012 |
| Recalling firm | Tedan Surgical Innovations Llc |
| Firm location | Sugar Land, TX |
| Affected scope | 12,065 Sterile Distraction Screws (2413 boxes); 384 Sterile XL Screws (128 boxes) in distribution |
| Distribution | Worldwide distribution: USA (nationwide) and countries of : Australia and Taiwan. |
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-2385-2012) 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? ▼
Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Screws are intended for the distraction in the anterior approach to the cervical spine. Sterile XL Screws are intended for the fixation of the blade to the vertebral body to prohibit drifting in the extreme lateral approach to the lumbar spine.. Recalled by Tedan Surgical Innovations Llc. Units affected: 12,065 Sterile Distraction Screws (2413 boxes); 384 Sterile XL Screws (128 boxes) in distribution.
Why was this product recalled? ▼
This letter is to notify you that several of our sterile screw products are being voluntarily recalled. Product sterility may be compromised due to a mechanical failure of the protective packaging tube. Tube end plugs may dislodge creating the potential for the screw to come out of the protective tube and then the sharp end of the screw pierce the outer sterile barrier pouch.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 26, 2012. Severity: Moderate. Recall number: Z-2385-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: USA (nationwide) and countries of : Australia and Taiwan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2385-2012) 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 September 26, 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.