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U.S. Department of Health and Human Services

Class 2 Device Recall Onkos Surgical Inc. My3D Personalized Pelvic Implant

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 Class 2 Device Recall Onkos Surgical Inc. My3D Personalized Pelvic Implantsee related information
Date Initiated by FirmJuly 24, 2026
Date PostedOctober 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0090-2027
Recall Event ID 99692
510(K)NumberK212815 K223348 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
ProductOnkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Code Information UDI: B278PVACREC04M0-Lot# C26-0346; Case# C26-0346,
FEI Number 3013450937
Recalling Firm/
Manufacturer		 Onkos Surgical, Inc.
77 E Halsey Rd
Parsippany NJ 07054-3714
For Additional Information ContactGordon Ballard
201-274-6296
Manufacturer Reason
for Recall		Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
FDA Determined
Cause 2		Labeling mix-ups
ActionOn July 24, 2026, Onkos Surgical Inc. issued a medical device recall to affected consignees via email. Onkos Surgical Inc. informed consignees of the following actions to be taken: 1.Segregate and quarantine the product immediately. 2.Within two business days, complete the Product and Distribution Table within the medical device recall document and acknowledge receipt of this letter. 3. Return your existing implants for inspection within 2 business days after signing the acknowledgement. Return to: Onkos Surgical, Inc., Attention: Matt Avioli, 77 East Halsey Road, Parsippany, NJ 07054 4. Contact Matt Avioli for questions:Phone: 781-223-0938, Email contact: mavioli@onkossurgical.com
Quantity in Commerce1 implant
DistributionUS Nationwide distribution in the states of North Carolina, and California.
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 = LPH
510(K)s with Product Code = LPH
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