Z-2253-2019Class II

Go-EZ Screw 6.5x115, Item Number 19671 -

Name: Z-2253-2019 Go-EZ Screw 6.5x115, Item Number 19671 -
Creator: BioPro, Inc.
Published: 2019-06-25
License: https://open.fda.gov/license/

Biopro, Inc. / initiated 2019-06-25 / Terminated / root cause: manufacturing process

FDA source

BioPro, Inc. began a recall of Go-EZ Screw 6.5x115, Item Number 19671 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various... on 2019-06-25. FDA classified it as Class II and gives the reason as "Manufacturing flaw in the sterile barrier system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2253-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-25
Posted: 2019-08-12
Terminated: 2020-05-07
Recalling firm: Biopro, Inc.
Product: Go-EZ Screw 6.5x115, Item Number 19671 - 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
Product code: NBH Accessories, Arthroscopic
Reason for recall: Manufacturing flaw in the sterile barrier system
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 2 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
Product codes and lots: UDI - M209196710 Lot Number - 123118 MFG Date - 4/25/2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2253-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2239-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2240-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2241-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2242-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2243-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2244-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2245-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2246-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2247-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2248-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2249-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2250-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2251-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2252-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2253-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2254-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2255-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2256-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2257-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2258-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2259-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12

Product code NBH

K081149Class IIBiopro Go-Ez ScrewBiopro, Inc. / cleared 2008-08-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)