Z-2138-2015Class II

Attune Fb Cr Articulation Surface Size 3-8

Name: Z-2138-2015 Attune Fb Cr Articulation Surface Size 3-8
Creator: DePuy Orthopaedics, Inc.
Published: 2015-06-12
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2015-06-12 / Terminated / root cause: design

FDA source

DePuy Orthopaedics, Inc. began a recall of 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... on 2015-06-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2138-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-12
Posted: 2015-07-20
Terminated: 2015-11-12
Recalling firm: Depuy Orthopaedics Inc.
Product: 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 between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: URGENT INFORMATION: MEDICAL DEVICE CORRECTION was issued for all lots of the affected devices. The device correction is to inform US Distributors and Medical Professionals about the issue, how to prevent the issue, and any actions to take. US Distributors will provide Hospitals/User Facilities with the Medical Professional Notice and Acknowledgment Cards. US Distributors will also work with the sales consultants to ensure all consultants complete sales training regarding this issue.
Quantity in commerce: 42645 units
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, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Internationally to CANADA , AUSTRALIA, AUSTRIA, BELGIUM, ENGLAND/ UK, FRANCE, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JAPAN, MALAYSIA, NETHERLANDS, NEW ZEALAND, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN & IBERIA, SWEDEN, SWITZERLAND, THAILAND, UAE, CHILE, COLOMBIA, MEXICO, PERU, and PUERTO RICO.
Product codes and lots: Product Codes: 254500523, 254500524, 254500525, 254500526, 254500527, and 254500528. GTIN: 10603295132639, 10603295132646, 10603295132653, 10603295132660, 10603295132677, and 10603295132684.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2138-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2137-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2138-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2139-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2140-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2141-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2142-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2143-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2144-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2145-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2146-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20

Product code MBH

K140881Class IIDepuy Attune Knee System - Cementless Cr and Ps Femoral ComponenetsDepuy(Ireland) / cleared 2015-02-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)