Z-1374-2021Class II

Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy

Name: Z-1374-2021 Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy
Creator: Arrow International Inc
Published: 2021-03-08
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2021-03-08 / Open, Classified / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold in... on 2021-03-08. FDA classified it as Class II and gives the reason as "Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Use of a defective device is likely to require immediate repeat biopsy, leading to a...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1374-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-03-08
Posted: 2021-04-07
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended for bone biopsy of the vertebral body and bone lesions.
Product code: KNW Instrument, Biopsy
Reason for recall: Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Use of a defective device is likely to require immediate repeat biopsy, leading to a prolonged procedure
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Teleflex issued to US consignee notification letter on March 8, 2021 via FedEx 2-day mail. Letter states reason for recall, health risk, and action to take: Action list number 1 Medical facilities 1. We request that you check your inventory for product within the scope of this FSCA. Users should cease use and distribution of impacted product and quarantine immediately. 2. If you do not have stock in scope of this FSCA mark the according checkbox on the Acknowledgement Form (Appendix 1) and return the form to the fax number or e-Mail address mentioned below. 3. If you do have stock in scope of this FSCA, mark the according checkbox on the Acknowledgement Form (Appendix 1) and contact customer service by calling the phone number mentioned below. Customer service will issue you with a return number. Write the return number into the respective field in the Acknowledgement Form and return this form immediately to Customer Service. 4. Teleflex (or your local dealer) will issue a credit note upon receipt of the returned affected product. Action list number 2 Distributors 1. Provide this field safety notice to all customers who have received product in scope of this FSCA. Your customer is then required to complete the acknowledgement form and return to you. 2. We request that you check your inventory for product within the scope of this FSCA. Cease use and distribution of impacted product and quarantine immediately. You may then return all product in scope. 3. As a distributor, you are then required to confirm to Teleflex that you have completed the field activity outlined above. Upon completion of your actions, please forward the completed Acknowledgement Form to Customer Service. 4. If you have further distributed product outside of your country, please notify Teleflex by return email to the e-Mail address below. Should you require any further information or support concerning this issue, please contact: Customer Service: Contact: Customer Serv
Quantity in commerce: 3,756 units (US); 249 units (OUS) Expanded 810 units: 774 US and 36 OUS
Distribution: US Nationwide distribution.
Product codes and lots: Lot Numbers US: 39647326 39647327 39647328 40422734 40422735 Lot Number: 40808740 (EU) EXPANDED RECALL: 5/4/21 Lot Numbers: 38347967 40422740

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1374-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1374-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-14	2021-04-07

Product code KNW

K113872Class IIThe Oncontrol Bone Access and Bone Biopsy System by VidacareVidacare Corporation / cleared 2012-03-08

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)