Z-1503-2020Class II

D-0012 3Cor 12Mm Distraction Screws, 5/Box, Sterile -

Name: Z-1503-2020 D-0012 3Cor 12Mm Distraction Screws, 5/Box, Sterile -
Creator: TeDan Surgical Innovations LLC
Published: 2019-02-18
License: https://open.fda.gov/license/

Tedan Surgical Innovations, Inc. / initiated 2019-02-18 / Terminated / root cause: manufacturing process

FDA source

TeDan Surgical Innovations LLC began a recall of D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are... on 2019-02-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1503-2020
Classification: Class II
Status: Terminated
Initiated: 2019-02-18
Posted: 2020-03-17
Terminated: 2021-01-12
Recalling firm: Tedan Surgical Innovations, Inc.
Product: 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.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 02/21/2019 the firm issued a recall notice to affected consignees. The recall notification informed the consignees of the following: Customers should immediately remove all identified products and contact TSI to receive an RMA and shipping instructions. 2. Contact information for returns: Name: Nicole Burrell or Val Saucedo Telephone: 713 726-0886 Email address: custservice@ tedansurgica.com Fax 713 726-0846 In addition, if you have distributed the identified product to end users, immediately identify all customers and notify them of this product recall in writing using the enclosed information. Your assistance is appreciated and necessary to prevent any possible injury to patients. Also as needed provide to these customers the attached recall response form for their completion and provide to TSI the name, address, and contact information for those customers. Other TSI distraction screws not identified as part of this recall may be used. However, as a precaution, always follow the instructions for use and carefully inspect sterile packaging for any breaches. If breaches are identified DO NOT USE THE PRODUCT and contact TSI immediately.
Quantity in commerce: 49 boxes (245 individual screws)
Distribution: Worldwide.
Product codes and lots: Item #: D-0012 Lot #: 2018011601

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1503-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1503-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-17
Z-1504-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-17
Z-1505-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-17
Z-1506-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-17

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)