Device recall: Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300

Class II FDA enforcement event 88304. Recall start date: 2 Jun 2021. Status in the FDA record: Terminated. Termination date: 6 Jul 2022.

Reason for recall, in the words of FDA

Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Biomet, Inc. started this device recall on 2 Jun 2021. The firm address in the FDA record is in Warsaw, IN. FDA put the recall in Class II. FDA event 88304 has 17 product records. The first FDA enforcement report date is 18 Aug 2021. The record gives the status Terminated, with the termination date 6 Jul 2022.

FDA enforcement report The 17 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US Nationwide distribution.

Recalling firm

Biomet, Inc., Warsaw, IN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

17 product records in the event.

FDA event 88304: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2259-2021	Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300	88 units	Class II	Terminated	18 Aug 2021
Z-2260-2021	Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301	N/A	Class II	Terminated	18 Aug 2021
Z-2261-2021	Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number: 11-301302	21 units	Class II	Terminated	18 Aug 2021
Z-2262-2021	Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number: 11-301310	81 units	Class II	Terminated	18 Aug 2021
Z-2263-2021	Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number: 11-301311	22 units	Class II	Terminated	18 Aug 2021
Z-2264-2021	Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312	33 units	Class II	Terminated	18 Aug 2021
Z-2265-2021	Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item Number: 11-301314	10 units	Class II	Terminated	18 Aug 2021
Z-2266-2021	Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM Item Number: 11-301315	7 units	Class II	Terminated	18 Aug 2021
Z-2267-2021	Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM Item Number: 11-301321	11 units	Class II	Terminated	18 Aug 2021
Z-2268-2021	Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number: 11-301322	11 units	Class II	Terminated	18 Aug 2021
Z-2269-2021	Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325	11 units	Class II	Terminated	18 Aug 2021
Z-2270-2021	Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Item Number: 11-301331	N/A	Class II	Terminated	18 Aug 2021
Z-2271-2021	Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Item Number: 11-301333	12 units	Class II	Terminated	18 Aug 2021
Z-2272-2021	Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item Number: 11-301335	N/A	Class II	Terminated	18 Aug 2021
Z-2273-2021	Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Item Number: 11-301342	12 units	Class II	Terminated	18 Aug 2021
Z-2274-2021	Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number: 11-301343	N/A	Class II	Terminated	18 Aug 2021
Z-2275-2021	Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM Item Number: 11-301354	12 units	Class II	Terminated	18 Aug 2021

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2021: 900
Share of these events in Class II: 89%
Product records in this event: 17Median of the firm: 1
Events of the firm on the register: 84

Other events of the firm

Other FDA enforcement events of Biomet, Inc.
Initiated	Product (first record)	Type	Class	Records
1 Jul 2026	Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade A	Device	Class II	5
23 Sep 2025	BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Rep	Device	Class II	1
9 Sep 2025	Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080	Device	Class II	1
21 Oct 2024	JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357	Device	Class II	1
17 May 2024	RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206	Device	Class II	1
13 Mar 2024	Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foi	Device	Class II	1
2 Nov 2023	Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01	Device	Class II	2
9 Oct 2023	Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ	Device	Class II	19
6 Feb 2023	G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462	Device	Class II	1
29 Dec 2022	(1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number:	Device	Class II	2

Biomet, Inc.: all 84 events

Official channels

FDA enforcement report Z-2259-2021The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 88304. https://recallregister.com/fda/ii/88304/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US Nationwide distribution.
What quantity of product is in FDA event 88304?: The event has 17 product records. The first record gives this quantity: 88 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2021 have the same class?: 89% of the 900 device events that started in 2021 are in Class II.