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U.S. Department of Health and Human Services

Class 2 Device Recall ES2 SPINAL SYSTEM

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 Class 2 Device Recall ES2 SPINAL SYSTEMsee related information
Date Initiated by FirmOctober 02, 2026
Date PostedNovember 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0440-2027
Recall Event ID 100141
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductNITINOL K-WIRE BLUNT; Catalog/Part Number: 48280232; used in spinal surgery
Code Information Catalog/Part Number: 48280232; UDI-DI: 07613327096200; Serial/Lot Number(s) Affected: 25A459, 25A460, 25A461, 25A462, 25A463, 25A464, 25A465, 25A466, 25A467, 25A468, 25A469, 25A470, 25A471, 25A472, 25A473, 25A474, 25A475, 25A476, 25A477, 25A478, 25A479, 25A480, 25A481, 25A482, 25A483, 25A484, 25A485, 25A486, 25A487, 25A488, 25A489, 25A490, 25A491, 25A492, 25A493, 25A494, 25A495, 25A496, 25A497, 25A498, 25A499, 25A500, 25A501, 25A502, 25A503, 25A504, 25A505, 25A506, 25A507, 25A508, 25A509, 25A513, 25A512, 25A514, 25A515, 25A511, 25A510, 25A516, 25A517, 25A518, 25A519, 25A522, 25A525, 25A520, 25A521, 25A523, 25A524, 25A526;
FEI Number 3037159684
Recalling Firm/
Manufacturer		 VB SPINE LLC
505 Park Ave Fl 14
New York NY 10022-1106
For Additional Information ContactIsabel Garza
201-749-8000
Manufacturer Reason
for Recall		Potential for the K-wire to fracture during use resulting in procedural delay and possibility of a piece of fractured K-wire remaining in the patient's bone.
FDA Determined
Cause 2		Process control
ActionOn October 2, 2026 Urgent: Medical Device Recall letters were sent to customers. Actions to be taken: 1. Review the Product Recall Notification. Please forward this information to all appropriate personnel within your organization. 2. Please check your internal inventory to locate the product. We recommend using a visual aid (e.g., magnification) to identify lot numbers. 3. Please work with your account s VB Spine Sales Representative to complete the Business Reply Form to identify any affected product. Complete the Business Reply Form even if there is no affected product identified. 4. The VB Spine Sales Representative will arrange for retrieval and removal of any affected product associated with this recall. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. 6. Inform VB Spine if the affected product has been distributed to any other individuals, organizations, or entities. If so, provide contact details in the Business Reply Form attached so that VB Spine can inform the recipients appropriately.
Quantity in Commerce12268
DistributionDomestic: Nationwide Distribution; International: Australia, Belgium, France, Ireland, Italy, Japan, Netherlands, Spain, United Kingdom;
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.
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