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U.S. Department of Health and Human Services

Class 2 Device Recall BioPro Femoral Head

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 Class 2 Device Recall BioPro Femoral Headsee related information
Date Initiated by FirmSeptember 09, 2025
Date PostedOctober 14, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0151-2026
Recall Event ID 97605
510(K)NumberK912641 
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
ProductBioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024 HEAD FEMORAL CERAMIC 28MM +0 19025 HEAD FEMORAL CERAMIC 32MM -3 19026 HEAD FEMORAL CERAMIC 32MM +0 19027 HEAD FEMORAL CERAMIC 32MM +3
Code Information Product ID/UDI-DI 19023 M20919023 19024 M20919024 19025 M20919025 19026 M20919026 19027 M20919027 All lots, all serial numbers
Recalling Firm/
Manufacturer		 BioPro, Inc.
2929 Lapeer Rd
Port Huron MI 48060-2558
For Additional Information ContactMr. Patrick Pringle
810-982-7777
Manufacturer Reason
for Recall		Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
FDA Determined
Cause 2		Package design/selection
ActionConsignees were notified on September 9, 2025, via phone, followed by formal letters with instructions for returning the inventory to BioPro.
Quantity in Commerce147 total
DistributionUS Domestic distribution to Texas and Michigan.
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 = LZO
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