CLASS III Device recall · Reported 12 Oct 2016 · FDA Enforcement Report

Suture Washer recalled by Arthrex

Arthrex is recalling Arthrex Suture Washer, distributed in 9 states. The recall was initiated on 12 Aug 2016 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesUnique Device Identifier (UDI): 00888867118607; Catalog # AR-7000-18T; Batch #10028617.

Quantity recalled45 devices

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-2918-2016
FDA event ID: 75050
Recalling firm: Arthrex, Naples, FL
Classification: Class III
Status: Terminated
Recall initiated: 12 Aug 2016
FDA classified: 30 Sep 2016
Reported: 12 Oct 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Surgical Instruments

Timeline

12 Aug 2016	Recall initiated by company
30 Sep 2016	Classified by FDA	+49 days
12 Oct 2016	Published in enforcement report	+12 days

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

Reason for recall

The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Arthrex Suture Washer

Where it was distributed

OR, NY, MN, KY, CA, ID, CO, MA, and FL. Thailand.

California Colorado Florida Idaho Kentucky Massachusetts Minnesota New York Oregon

Questions about this recall

Is Suture Washer recalled?

Yes. Arthrex recalled Suture Washer on 12 Aug 2016. The recall is Class III and its status is Terminated. Recall number Z-2918-2016.

Why was it recalled?

The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.

Which lots are affected?

Unique Device Identifier (UDI): 00888867118607; Catalog # AR-7000-18T; Batch #10028617.

Where was it sold?

OR, NY, MN, KY, CA, ID, CO, MA, and FL. Thailand.

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Arthrex

All 28

Reported	Class	Recall	Company	Reason	Where
14 Dec 2022Device	CLASS II	Small Joint OATS Set recalled by Arthrex	Arthrex	Sterility	20 states
11 May 2022Device	CLASS II	K-Wire, 1.35 mm x 170 mm recalled by Arthrex	Arthrex	Other	Nationwide
28 Jul 2021Device	CLASS II	Suture Anchor, BioComposite SwiveLock C, Closed Eyelet recalled	Arthrex	Sterility	Nationwide
21 Apr 2021Device	CLASS II	Tibial Opening Wedge Osteotomy Plate, Titanium recalled by Arthrex	Arthrex	Other	Nationwide
7 Apr 2021Device	CLASS II	Drill Bit, Cannulated recalled by Arthrex	Arthrex	Other	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide