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 conne
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics, Inc. is recalling 3,474 units of ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 Tibial Articulation Surface Trial instruments used during knee surgery planning. The recalled product has product codes 254500961 and 254500962. The instruments contain a small wire spring coil called a Balseal located on a post feature that can become damaged and separate from the post during use.
If the Balseal separates from the post, it could enter the surgical site and potentially be left inside the patient if the surgeon does not notice it has come off. The recalled devices were distributed worldwide, including throughout all U.S. states and territories, as well as to Canada, Australia, and multiple other countries. The recall source does not specify what remedy an affected consumer should pursue.
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: 3474 units Lot/code info: Product Codes:254500961 and 254500962. GTIN: 10603295135388 and 10603295135395.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.