ATTUNE CONV FB CR TB TRL SZ3 - 10 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 for
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics, Inc. is recalling 14,756 units of ATTUNE Knee Tibial Articulation Surface trial instruments used during knee surgery procedures. The instruments contain a small wire spring coil called a Balseal that can become damaged and separate from its post during use. If the Balseal separates without the surgeon noticing, it could enter the surgical site and potentially be left inside the patient.
The affected product codes are 254501963, 254501964, 254501965, 254501966, 254501967, 254501968, 254501969, and 254501970. The recall applies to products distributed worldwide, including throughout the United States and internationally to countries including Canada, Australia, Austria, Belgium, France, Germany, Japan, and others. The source document does not specify a remedy or action 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: 14756 units Lot/code info: Product Codes:254501963, 254501964, 254501965, 254501966, 254501967, 254501968, 254501969, and 254501970. GTIN: 10603295423355, 10603295423362, 10603295423379, 10603295423386, 10603295423393, 10603295423409, 10603295423416, and 10603295423423.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.