ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial… — Class II medical device recall Z-2145-2015
Terminated recall by DePuy Orthopaedics, Inc., reported 2015-07-29, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Arti
| Recall number | Z-2145-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2015-06-12 |
| Classified | 2015-07-20 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2015-11-12 |
| Distributed | 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, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CL, CO, DE, ES, FR, GB, HK, ID, IE, IL, IN, IT, JP, KR, MX, MY, NL, NZ, PE, SE, SG, SK, TH, ZA |
| Quantity | 3,474 units |
| UPC / GTIN / UDI-DI | 10603295135388, 10603295135395 |
Product
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 between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2145-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.