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 conne
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics, Inc. is recalling ATTUNE RP CR Articulation Surface knee instruments (sizes 3-8) used during knee replacement surgery trials worldwide, including all U.S. states and multiple international locations. The recall affects 56,368 units with product codes 254500563 through 254500568. The problem involves a small wire spring coil called a Balseal located on the instrument's post feature that can become damaged and separate during use.
If the Balseal becomes detached during the surgical trial process, 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 any remedy or actions for affected consumers.
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: 56368 units Lot/code info: Product Codes: 254500563, 254500564, 254500565, 254500566, 254500567, and 254500568. GTIN: 10603295133032, 10603295133049, 10603295133056, 10603295133063, 10603295133070, and 10603295133087.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.