ATTUNE CONV RP PS TB TRL SZ10 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 b
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics is recalling approximately 5,185 units of ATTUNE Knee Tibial Articulation Surface Trial instruments used during knee replacement surgery. The recalled instruments contain a small wire spring coil called a Balseal located on the post feature. This component can become damaged and separate from the post during the surgical trial process.
If the Balseal separates from the post, it could enter the surgical site and potentially remain inside the patient without the surgeon's knowledge. The recalled instruments were distributed worldwide, including throughout all U.S. states and territories and internationally to countries including Canada, Australia, the United Kingdom, France, Germany, Japan, and India. The recall notice does not specify what action affected consumers should take.
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: 5185 units Lot/code info: Product Codes:254501000 and GTIN: 10603295135777
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.