Z-2527-2020Class II

Phantom Cs Distraction Screw, 14 Mm, Sterile, 5/Box -

Name: Z-2527-2020 Phantom Cs Distraction Screw, 14 Mm, Sterile, 5/Box -
Creator: TeDan Surgical Innovations LLC
Published: 2020-05-15
License: https://open.fda.gov/license/

Tedan Surgical Innovations, Inc. / initiated 2020-05-15 / Terminated / root cause: packaging

FDA source

TeDan Surgical Innovations LLC began a recall of PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine on 2020-05-15. FDA classified it as Class II and gives the reason as "Lack of pouch seal. Product is labelled as sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2527-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-15
Posted: 2020-07-10
Terminated: 2022-09-08
Recalling firm: Tedan Surgical Innovations, Inc.
Product: PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Lack of pouch seal. Product is labelled as sterile.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: On June 4, 2020, the firm sent an "URGENT: MEDICAL DEVICE FIELD SAFETY NOTICE" along a "Field Safety Notice Acknowledgement and Receipt Form Response Required" to customers via email informing them the Recaling Firm has received two (2) complaints associated with the packaging issue where there was no seal on the screw pouch opposite the chevron manufacturing pouch seal. The Recalling Firm is instructing customer to: -immediate visual inspection of the pouch be conducted (Letter A shown in the red outline opposite the chevron seal [Letter B] in Figure 1) and observe for an open seal (example photographs are included in the Notification). Any product exhibiting an open seal is to be quarantined, and then returned to the Recalling Firm. Customers are to contact their authorized distributor for RMA and shipping instructions. The Recalling Firm requests the following actions be performed to visually inspect the product packaging: 1. Carefully open the Distraction Screw box only on one (1) end, ensuring box integrity. 2. Remove the five (5) sterile pouches. 3. Visually inspect the seal zone (indicated as letter A in Figure 1) opposite the chevron seal (Letter B) for each sterile pouch. 4. IF the pouch is not sealed, DO NOT USE THE DEVICE. Quarantine the device and contact your authorized distributor who will assist you with shipping instructions and replacements. See contact information below. 5. IF the pouch is sealed, is not opened, the product remains sterile and may be used. 6. Complete and return to TSI the enclosed FIELD SAFETY NOTICE ACKNOWLEDGMENT via fax or e-mail. Please complete as soon as possible but no later than July 6, 2020. Contact Information for Returns - RMA: Account Management Telephone 713-726-0886 Email Address [email protected] Fax 713-726-0846 For further questions, contact Lynne Davies, [email protected] or call 713-554-2130
Quantity in commerce: 1965 screws (packaged into 393 boxes) - [5 screw per box]
Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of: AZ, CA, FL, GA, HI, IL, MA, MI, NC, NH, NJ, NY, NV, PA, PR, TN, TX, and WA . The countries of Australia, Canada, France, Philippines, Taiwan, U.A.E., and United Kingdom.
Product codes and lots: Product Code: DS-0014 UDI Number: 00851797006450 Lot Number: 2018020801 2018061101

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2527-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2524-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-07
Z-2525-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-07
Z-2526-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-07
Z-2527-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-07
Z-2528-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-07
Z-2529-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-07
Z-2530-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-07

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)