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 conne
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics is recalling ATTUNE RP PS Articulation Surface instruments in sizes 3-8, which are trial instruments used during knee replacement surgery. The recall affects 61,556 units distributed worldwide, including all U.S. states and multiple international countries. The recalled products have product codes 254500543 through 254500548.
A small wire spring coil called a Balseal, located on the post feature of these trial instruments, may become damaged and separate from the instrument. If the Balseal disassociates during surgery, it could enter the surgical site and potentially be left inside the patient if the surgeon does not notice it has come off. The recall record does not specify a remedy or what consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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, M Quantity: 61556 units Lot/code info: Product Codes: 254500543, 254500544, 254500545, 254500546, 254500547, and 254500548. GTIN: 10603295132837, 10603295132844, 10603295132851, 10603295132868, 10603295132875, and 10603295132882.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.