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U.S. Department of Health and Human Services

Class 2 Device Recall BioPro

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 Class 2 Device Recall BioProsee related information
Date Initiated by FirmSeptember 09, 2025
Date PostedOctober 14, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0153-2026
Recall Event ID 97605
510(K)NumberK872856 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
ProductBioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 HEAD FEMORAL 32 LG LT
Code Information Product ID/UDI-DI 14089 M20914089 14090 M20914090 14091 M20914091 14094 M20914094 14095 M20914095 14096 M20914096 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 = JDI
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