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U.S. Department of Health and Human Services

Class 2 Device Recall Reef TA Inserter

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 Class 2 Device Recall Reef TA Insertersee related information
Date Initiated by FirmAugust 06, 2025
Date PostedSeptember 11, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2554-2025
Recall Event ID 97190
510(K)NumberK192132 
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
ProductReef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
Code Information UDI-DI: 10889981290733, 10889981437800. Lots: BT107376C, BT112289C, BT112779C, BT107376CR1, BT107376CR2, BT107376CR1R2, BT112289CR2, BT112779CR2
Recalling Firm/
Manufacturer		 SEASPINE ORTHOPEDICS CORPORATION
5770 Armada Dr
Carlsbad CA 92008-4608
For Additional Information Contact
760-224-0177
Manufacturer Reason
for Recall		Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.
FDA Determined
Cause 2		Device Design
ActionOn 8/6/2025, recall notices were emailed to customers and distributors who were informed of the following: A laser marking error was identified in which the TA2-001003 inserters were incorrectly marked with the UDI-DI for model TA2-001002 (10889981290733). Updated Revision E Inserters have been shipped to you via overnight delivery. Kindly replace all existing Revision C/R1/R2 Inserters with the enclosed Revision E units. Return the Revision C Inserters to the recalling firm using provided RGA and prepaid shipping label. This recall notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred. Should you have any questions regarding this matter, please contact the firm at: dominiquepetach@orthofix.com
Quantity in Commerce74
DistributionWorldwide - US Nationwide distribution in the states of NV, TX, ID, MI, OH, SD, TN, PA, CT, CO, FL, WA, NC, OK, MN and the country of Hong Kong.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MAX
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