K-Wire HBS Sterile Lot, 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
FDA Recall Z-2259-2019 · Posted None
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Recalling FirmBioPro, Inc.
Recall StatusTerminated
Product CodeNBH
Date Initiated2019-06-25
Date Terminated2020-05-07
Product Quantity17 units
Reason for Recall
Manufacturing flaw in the sterile barrier system
Firm Action
On 6/25/2019, BioPro contacted all customers via telephone. BioPro subsequently emailed all customers a list of impacted products to include details of how products should be returned and actions to be taken.
Customers were advised to take the following action:
1) Identify and segregate impacted product.
2) BioPro will send a return shipping label to facilitate a smooth return of product. Reference RMA # when product is returned.
Customers with questions may call 1-800-252-7707.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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