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.

Recall Insight

This FDA Devices action (record #Z-2239-2019) was formally reported on August 21, 2019, with the manufacturer initiating the action on June 25, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. BioPro, Inc. is listed as the recalling firm, operating out of Port Huron, MI. Federal records indicate 17 units units are affected.

The documented reason for this recall is: Manufacturing flaw in the sterile barrier system Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 7 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.