BioPro K-Wire HBS Sterile Recalled for Sterile Barrier Flaw
BioPro, Inc. is recalling 17 units of K-Wire HBS Sterile due to a manufacturing flaw in the sterile barrier system.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a sterile barrier flaw, which poses a risk of infection (risk-of-harm product), but no specific injuries or illnesses are reported in the source text.
Plain-English summary
BioPro, Inc. is recalling 17 units of K-Wire HBS Sterile, Item Number 19688. These medical devices are accessories to the BioPro Go-Ez screw system and the BioPro HBS System, intended for various orthopedic surgical procedures but not for use in the spine.
The recall is due to a manufacturing flaw in the sterile barrier system. The affected units have UDI M209196880, Lot Number 122572, and a manufacture date of 4/23/2019.
The products were distributed worldwide, including in the US states of FL, LA, MD, NC, NY, OR, and TX, as well as in Ecuador and Scotland. Healthcare providers and consumers should stop using the affected products and contact BioPro, Inc. for further instructions.
The recalled product
- Product
- K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine.
- Manufacturer
- BioPro, Inc.
- Affected units
- 17
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI M209196880 Lot Number - 122572 MFD Date - 4/23/2019
Distribution
Part of a larger recall action
This product is one of 21 recalled by BioPro, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 21 products in this recall →Related recalls
Same manufacturer · BioPro, Inc.
See all →- HighUni-polar endo heads recalled over packaging that may compromise sterility
FDA (Devices) · 2025-10-22
- HighMetal and ceramic femoral heads recalled over sterile barrier packaging defect
FDA (Devices) · 2025-10-22
- HighCeramic femoral heads recalled over packaging that may compromise sterile barrier
FDA (Devices) · 2025-10-22
- HighFemoral head implants recalled over packaging that may compromise sterile barrier
FDA (Devices) · 2025-10-22
- HighCeramic endo modular heads recalled over sterile barrier packaging defect
FDA (Devices) · 2025-10-22
Same hazard · sterile barrier flaw
See all →- HighBioPro K-Wire Single Trocar Recalled for Sterile Barrier Flaw
FDA (Devices) · 2019-08-21
- HighBioPro Go-EZ Screw Recalled Due to Sterile Barrier Manufacturing Flaw
FDA (Devices) · 2019-08-21
- HighBioPro K-Wire Sterile Single Trochar Recalled for Sterile Barrier Flaw
FDA (Devices) · 2019-08-21
- HighBioPro Go-EZ Screw Recalled Due to Sterile Barrier Flaw
FDA (Devices) · 2019-08-21
- HighBioPro Go-EZ Screw Recalled Due to Sterile Barrier Flaw
FDA (Devices) · 2019-08-21
Similar recalls
- HighHowmedica Recalls 15 Pouches of Sterile Knee Instruments Due to Barrier Risk
FDA (Devices) · 2018-11-14
- ModerateZimmer Biomet Recalls K-Wire Trochar Tips Due to Packaging Seal Issues
FDA (Devices) · 2019-07-10
- HighECONO STERILE Orthopedic Probes Recalled for Sterile Barrier Breach Risk
FDA (Devices) · 2025-01-22
- HighMicroAire Kirschner-Wire Recall Due to Defective Sterile Pouch Seals
FDA (Devices) · 2013-09-11
- SevereZimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise
FDA (Devices) · 2018-12-12
- HighGynecological Procedure Kits Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2025-01-22