Device recall: BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.

FDA enforcement event 85153 · Class II · initiated 26 Feb 2020 · status Terminated · terminated 29 Jul 2021

DeviceVoluntary: Firm initiated33 product recordsWarsaw, IN

FDA enforcement event 85153 is a device recall by Biomet, Inc. of Warsaw, IN, initiated 26 Feb 2020 and classified Class II, with 33 product records.

FDA defines Class II as 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. 93% of the 916 device enforcement events initiated in 2020 carry the same class.

Status: Terminated, terminated 29 Jul 2021. Initiation: voluntary: firm initiated. Biomet, Inc. has 84 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Biomet, Inc., Warsaw, IN.

Reason for recall

"Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters."

Distribution

"Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois,…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1638-2020	BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.	230,001	Class II	Terminated	15 Apr 2020
Z-1639-2020	BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.	230,001	Class II	Terminated	15 Apr 2020
Z-1640-2020	BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.	230,001	Class II	Terminated	15 Apr 2020
Z-1641-2020	BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.	230, 001	Class II	Terminated	15 Apr 2020
Z-1642-2020	BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.	230, 001	Class II	Terminated	15 Apr 2020
Z-1643-2020	BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.	230,001	Class II	Terminated	15 Apr 2020
Z-1644-2020	BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.	230,001	Class II	Terminated	15 Apr 2020
Z-1645-2020	BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.	230,001	Class II	Terminated	15 Apr 2020
Z-1646-2020	BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.	230,001	Class II	Terminated	15 Apr 2020
Z-1647-2020	BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.	230,001	Class II	Terminated	15 Apr 2020
Z-1648-2020	BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.	230,001	Class II	Terminated	15 Apr 2020
Z-1649-2020	BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.	230,001	Class II	Terminated	15 Apr 2020
Z-1650-2020	BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.	230,001	Class II	Terminated	15 Apr 2020
Z-1651-2020	BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.	230,001	Class II	Terminated	15 Apr 2020
Z-1652-2020	BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.	230,001	Class II	Terminated	15 Apr 2020
Z-1653-2020	BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.	230,001	Class II	Terminated	15 Apr 2020
Z-1654-2020	BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.	230,001	Class II	Terminated	15 Apr 2020
Z-1655-2020	BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.	230,001	Class II	Terminated	15 Apr 2020
Z-1656-2020	BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.	230,001	Class II	Terminated	15 Apr 2020
Z-1657-2020	BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.	230,001	Class II	Terminated	15 Apr 2020
Z-1658-2020	BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.	230,001	Class II	Terminated	15 Apr 2020
Z-1659-2020	BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.	230,001	Class II	Terminated	15 Apr 2020
Z-1660-2020	BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.	230,001	Class II	Terminated	15 Apr 2020
Z-1661-2020	BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.	230,001	Class II	Terminated	15 Apr 2020
Z-1662-2020	BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.	230,001	Class II	Terminated	15 Apr 2020
Z-1663-2020	BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.	230,001	Class II	Terminated	15 Apr 2020
Z-1664-2020	BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.	230,001	Class II	Terminated	15 Apr 2020
Z-1665-2020	BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.	230,001	Class II	Terminated	15 Apr 2020
Z-1666-2020	BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.	230,001	Class II	Terminated	15 Apr 2020
Z-1667-2020	BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.	230,001	Class II	Terminated	15 Apr 2020
Z-1668-2020	BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.	230,001	Class II	Terminated	15 Apr 2020
Z-1669-2020	BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.	230,001	Class II	Terminated	15 Apr 2020
Z-1670-2020	BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI Instrument, Sterile, Item CP161972.	1	Class II	Terminated	15 Apr 2020

Context

93%of 2020 device events are Class II916 events that year

33product records in this eventfirm median: 1

84events on this register for the firm

Other enforcement events for 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

All 84 events for Biomet, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is 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.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois,…"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 29 Jul 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.