CLASS II Device recall · Reported 23 Dec 2020 · FDA Enforcement Report

Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0 recalled

Biomet is recalling Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, distributed nationwide in the US. The recall was initiated on 25 Nov 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots 180720 334220 285750 285760

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0617-2021
FDA event ID: 86896
Recalling firm: Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 25 Nov 2020
FDA classified: 17 Dec 2020
Reported: 23 Dec 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

25 Nov 2020	Recall initiated by company
17 Dec 2020	Classified by FDA	+22 days
23 Dec 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810, 110009821, 110009825, 110009852 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.

Where it was distributed

Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN

Nationwide

Questions about this recall

Why was it recalled?

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Which lots are affected?

Lots 180720 334220 285750 285760

Where was it sold?

Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

15 other products · FDA event 86896

This product is part of a recall event; the main page for the event is Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0 recalled.

Reported	Class	Recall	Company	Reason	Where
23 Dec 2020	CLASS II	Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0 recalled	Biomet	Sterility	Nationwide
23 Dec 2020	CLASS II	Comprehensive Total Shoulder System/Bio-Modular Choice recalled	Biomet	Sterility	Nationwide
23 Dec 2020	CLASS II	Oxford Fixed Lateral recalled by Biomet	Biomet	Sterility	Nationwide
23 Dec 2020	CLASS II	Custom Cancellous Thread recalled by Biomet	Biomet	Sterility	Nationwide
23 Dec 2020	CLASS II	Sterile Trac System Thinflap Burr Hole Plate recalled by Biomet	Biomet	Sterility	Nationwide
23 Dec 2020	CLASS II	Phoenix, Interlocking screw for IM nail recalled by Biomet	Biomet	Sterility	Nationwide
23 Dec 2020	CLASS II	M/h Modular Stem recalled by Biomet	Biomet	Sterility	Nationwide
23 Dec 2020	CLASS II	OSS Polyethylene Tibial Bushing recalled by Biomet	Biomet	Sterility	Nationwide
23 Dec 2020	CLASS II	Ringloc Bipolar Hip System Bi Polar Locking Ring recalled by Biomet	Biomet	Sterility	Nationwide
23 Dec 2020	CLASS II	Comprehensive Reverse Shoulder System recalled by Biomet	Biomet	Sterility	Nationwide
23 Dec 2020	CLASS II	Ringloc Acetabular System Self-tapping bone screws recalled by Biomet	Biomet	Sterility	Nationwide
23 Dec 2020	CLASS II	Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0 recalled	Biomet	Sterility	Nationwide
23 Dec 2020	CLASS II	Titanium IFS recalled by Biomet	Biomet	Sterility	Nationwide
23 Dec 2020	CLASS II	RingLoc+ Quick Connect Drill Bit recalled by Biomet	Biomet	Sterility	Nationwide
23 Dec 2020	CLASS II	RapidFire Clip recalled by Biomet	Biomet	Sterility	Nationwide

More recalls from Biomet

All 279

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Device	CLASS II	Intramedullary Bone Saw Blade Assembly recalled by Biomet	Biomet	Sterility	IN
12 Aug 2026Device	CLASS II	Intramedullary Bone Saw Blade Assembly recalled by Biomet	Biomet	Sterility	IN
12 Aug 2026Device	CLASS II	Intramedullary Bone Saw Blade Assembly recalled by Biomet	Biomet	Sterility	IN
12 Aug 2026Device	CLASS II	Intramedullary Bone Saw Blade Assembly recalled by Biomet	Biomet	Sterility	IN
12 Aug 2026Device	CLASS II	Intramedullary Bone Saw Blade Assembly recalled by Biomet	Biomet	Sterility	IN

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide