Z-0677-2017Class II

ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy...

Name: Z-0677-2017 ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy...
Creator: Teleflex Medical
Published: 2016-11-08
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2016-11-08 / Terminated / root cause: design

FDA source

Teleflex Medical began a recall of ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral... on 2016-11-08. FDA classified it as Class II and gives the reason as "Sterility: Due to a potential incomplete seal on the outer sterile package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0677-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-08
Posted: 2016-11-30
Terminated: 2019-11-20
Recalling firm: Teleflex Medical
Product: ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.
Product code: KNW Instrument, Biopsy
Reason for recall: Sterility: Due to a potential incomplete seal on the outer sterile package.
Root cause tag: design
FDA root cause: Device Design
Action: Teleflex sent an Urgent Medical Device Recall Notification letter dated November 8, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any affected product, complete the enclosed Recall Acknowledgement Form and fax to 1-855-419-8507, Attn: Customer Service or email to [email protected]. Customers with questions were instructed to call their local sales representative or Customer Service at 1-866-246-6990. For questions regarding this recall call 919-433-4940.
Distribution: Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.
Product codes and lots: Material # 9461-VC-001, Lot numbers: 012579S, 013469S, 011227 & 011492; Material # 9461-VC-006, 011938, 012694, 013065, 013686 & 014615; Material # 9462-VC-001, Lot numbers: 010743S, 10778S, 010954S, 012580S & 012891S; Material # 9462-VC-006, Lot numbers: 010444, 010743, 010778, 010954, 011495, 011545, 011582, 011714, 012130, 012581, 013251, 013860, 013893, 014128 & 014316; Material # 9463-VC-001, Lot numbers: 010331S, 010955S, 011716S, 012133S & 013066S; Material # 9463-VC-006, Lot numbers: 010331, 010955, 011513, 011584, 011717, 011834, 012131, 012349, 013070, 013474, 013890, 013899, 014230, 014317 & 014616; Material # 9464-VC-001, Lot numbers: 010445S, 010744S, 010956S, 011718S, 012135S, 012695S & 013262S; Material # 9464-VC-006, Lot numbers: 010445, 010744, 010956, 011051, 011491, 011590, 011719, 011939, 012136, 012350, 012696, 012778, 013252, 013902, 014025, 014120, 014231, 014319, 014453 & 014618; Material # 9465-VC-001, Lot numbers: 010957S, 011940S & 014321S; Material # 9465-VC-006, Lot numbers: 010957, 011496, 011941, 012137, 012351, 013286, 013901 & 014322; Material # 9466-VC-001, Lot numbers: 010333S, 10844S, 010958S, 011722S & 012685S; Material # 9466-VC-006, Lot numbers: 010333, 010844, 010958, 011512, 011544, 011589, 011723, 012129, 012466, 013887, 014123, 014209 & 014323.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0677-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0675-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-11-30
Z-0676-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-11-30
Z-0677-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-11-30
Z-0678-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-11-30
Z-0679-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-11-30

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)