Device recall: ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with…

Class II FDA enforcement event 71421. Recall start date: 12 Jun 2015. Status in the FDA record: Terminated. Termination date: 12 Nov 2015.

Reason for recall, in the words of FDA

Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.

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

DePuy Orthopaedics, Inc. started this device recall on 12 Jun 2015. The firm address in the FDA record is in Warsaw, IN. FDA put the recall in Class II. FDA event 71421 has 10 product records. The first FDA enforcement report date is 29 Jul 2015. The record gives the status Terminated, with the termination date 12 Nov 2015.

FDA enforcement report The 10 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.

Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC,…

Recalling firm

DePuy Orthopaedics, 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

10 product records in the event.

FDA event 71421: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2137-2015	ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force…	34676 units	Class II	Terminated	29 Jul 2015
Z-2138-2015	ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force…	42645 units	Class II	Terminated	29 Jul 2015
Z-2139-2015	ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force…	61556 units	Class II	Terminated	29 Jul 2015
Z-2140-2015	ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a…	13964 units	Class II	Terminated	29 Jul 2015
Z-2141-2015	ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force…	56368 units	Class II	Terminated	29 Jul 2015
Z-2142-2015	ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force…	36607 units	Class II	Terminated	29 Jul 2015
Z-2143-2015	ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force…	11360 units	Class II	Terminated	29 Jul 2015
Z-2144-2015	ATTUNE CONV RP PS TB TRL SZ10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial…	5185 units	Class II	Terminated	29 Jul 2015
Z-2145-2015	ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force…	3474 units	Class II	Terminated	29 Jul 2015
Z-2146-2015	ATTUNE CONV FB CR TB TRL SZ3 - 10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the…	14756 units	Class II	Terminated	29 Jul 2015

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 2015: 1,153
Share of these events in Class II: 91%
Product records in this event: 10Median of the firm: 1
Events of the firm on the register: 59

Other events of the firm

Other FDA enforcement events of DePuy Orthopaedics, Inc.
Initiated	Product (first record)	Type	Class	Records
12 Mar 2024	ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacemen	Device	Class II	1
15 Feb 2023	Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118	Device	Class II	5
29 Jun 2022	ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the f	Device	Class II	1
18 May 2022	MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136	Device	Class II	1
11 Mar 2022	VELYS Robotic-Assisted Solution Base Product No.: 451570100	Device	Class II	1
5 Jan 2022	ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision su	Device	Class II	2
7 Dec 2021	GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610	Device	Class II	8
9 Sep 2021	ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001	Device	Class II	1
10 Aug 2021	TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical	Device	Class II	7
1 Jul 2021	ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080	Device	Class II	1

DePuy Orthopaedics, Inc.: all 59 events

Official channels

FDA enforcement report Z-2137-2015The 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.

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Cite this page

Recall Register. FDA enforcement event 71421. https://recallregister.com/fda/ii/71421/. 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: Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC,…
What quantity of product is in FDA event 71421?: The event has 10 product records. The first record gives this quantity: 34676 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2015 have the same class?: 91% of the 1,153 device events that started in 2015 are in Class II.