Device recall: Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American…
Class II FDA enforcement event 62899. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Tedan Surgical Innovations Llc started this device recall on 11 Jun 2012. The firm address in the FDA record is in Sugar Land, TX. FDA put the recall in Class II. FDA event 62899 has 1 product record. The first FDA enforcement report date is 26 Sep 2012. The record gives the status Terminated, with the termination date 31 Jul 2013.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution: USA (nationwide) and countries of : Australia and Taiwan.
Recalling firm
Tedan Surgical Innovations Llc, Sugar Land, TX.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2385-2012 | 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… | 12,065 Sterile Distraction Screws (2413 boxes); 384 Sterile XL Screws (128 boxes) in distribution | Class II | Terminated | 26 Sep 2012 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2012
- 823
- Share of these events in Class II
- 88%
- Product records in this event
- 1Median of the firm: 4
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 15 May 2020 | 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior appro | Device | Class II | 7 |
| 16 Jul 2019 | Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima | Device | Class II | 1 |
| 18 Feb 2019 | D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start | Device | Class II | 4 |
Official channels
- FDA enforcement report Z-2385-2012The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 62899. https://recallregister.com/fda/ii/62899/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution: USA (nationwide) and countries of : Australia and Taiwan.
- What quantity of product is in FDA event 62899?
- The FDA record gives this quantity:
12,065 Sterile Distraction Screws (2413 boxes); 384 Sterile XL Screws (128 boxes) in distribution
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2012 have the same class?
- 88% of the 823 device events that started in 2012 are in Class II.