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TSI recallZ-2528-2020 · TeDan Surgical Innovations LLC · initiated May 15, 2020

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from TeDan Surgical Innovations LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Lack of pouch seal. Product is labelled as sterile.

FDA root cause category: Packaging change control

What the company is doing

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

Recall details

Recall number
Z-2528-2020
Status
Terminated
Initiated by the company
May 15, 2020
Recalling firm
TeDan Surgical Innovations LLC
Quantity
730 screws (packaged into 146 boxes) - [5 screws per box]
Product code
LXH
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 description

PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.

Code information (models, lots, serial numbers)

Product Code: DS-0022 UDI Number: 00851797006474 Lot Number: 2018062901

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 85830).

Sources and updates

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