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Terminated

K-Wire Single Trocar 1.6x150mm, Item Number OL15016S - 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-2243-2019 · Posted None

Recalling FirmBioPro, Inc.
Recall StatusTerminated
Product CodeNBH
Date Initiated2019-06-25
Date Terminated2020-05-07
Product Quantity350 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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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