Recall Z-2244-2019
BioPro, Inc. · initiated June 25, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
K-Wire Single Trocar 1.1x150mm, Item Number OL15011S - 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
Codes / lots: UDI - M209OL15011S0 Lot Number - 123220 MFG Date - 4/23/2019
Reason for recall
Manufacturing flaw in the sterile barrier system
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-2244-2019
- Initiated
- June 25, 2019
- Terminated
- May 7, 2020
- Product code
- NBH – Accessories, Arthroscopic
- Quantity
- 350 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
- Recalling firm
- BioPro, Inc., Port Huron, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2239-2019 Class II | K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | 06/25/2019Terminated |
| Z-2240-2019 Class II | K-Wire Sterile Single Trochar, Item Number 19106 - Product Usage: Accessories to the…Manufacturing flaw in the sterile barrier system | 06/25/2019Terminated |
| Z-2241-2019 Class II | K-Wire Sterile Single Trochar .045, Item Number 19108 - Product Usage: Accessories to…Manufacturing flaw in the sterile barrier system | 06/25/2019Terminated |
| Z-2242-2019 Class II | K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - Product Usage: Accessories to the…Manufacturing flaw in the sterile barrier system | 06/25/2019Terminated |
| Z-2243-2019 Class II | K-Wire Single Trocar 1.6x150mm, Item Number OL15016S - Product Usage: Accessories to the…Manufacturing flaw in the sterile barrier system | 06/25/2019Terminated |
| Z-2245-2019 Class II | K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accessories to the…Manufacturing flaw in the sterile barrier system | 06/25/2019Terminated |
| Z-2246-2019 Class II | Go-EZ Screw 6.5x30, Item Number 19651 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | 06/25/2019Terminated |
| Z-2247-2019 Class II | Go-EZ Screw 6.5x100, Item Number 19668 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | 06/25/2019Terminated |
| Z-2248-2019 Class II | Go-EZ Screw 6.5x36, Item Number 19654 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | 06/25/2019Terminated |
| Z-2249-2019 Class II | Go-EZ Screw 6.5x95, Item Number 19667 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | 06/25/2019Terminated |
| Z-2250-2019 Class II | Go-EZ Screw 6.5x34, Item Number 19653 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | 06/25/2019Terminated |
| Z-2251-2019 Class II | Go-EZ Screw 6.5x85, Item Number 19665 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | 06/25/2019Terminated |
| Z-2252-2019 Class II | Go-EZ Screw 6.5x90, Item Number 19666 - Product Usage:Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | 06/25/2019Terminated |
| Z-2253-2019 Class II | Go-EZ Screw 6.5x115, Item Number 19671 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | 06/25/2019Terminated |
| Z-2254-2019 Class II | Go-EZ Screw 6.5x32, Item Number 19652 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | 06/25/2019Terminated |
| Z-2255-2019 Class II | Go-EZ Screw 6.5x105, Item Number 19669 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | 06/25/2019Terminated |
| Z-2256-2019 Class II | Go-EZ Screw 6.5x110, Item Number 19670 - Product Usage:Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | 06/25/2019Terminated |
| Z-2257-2019 Class II | Go-EZ Screw 6.5x120, Item Number 19672 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | 06/25/2019Terminated |
| Z-2258-2019 Class II | Go-EZ Screw 6.5x38, Item Number 19655 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | 06/25/2019Terminated |
| Z-2259-2019 Class II | K-Wire HBS Sterile Lot, Item Number 19688 - Product Usage: Accessories to the BioPro…Manufacturing flaw in the sterile barrier system | 06/25/2019Terminated |