ATTUNE FB PS ARTICULATION SURFACE SIZES 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 conn
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics, Inc. has recalled 34,676 units of ATTUNE FB PS Articulation Surface sizes 3-8 knee instruments used during surgical trials. The recalled product contains a small wire spring coil called a Balseal located on the post feature of the instrument. The hazard is that this Balseal can become damaged and separate from the post during use, and if this happens without the surgeon's awareness, the separated piece could enter the surgical site and be left inside the patient.
The recalled instruments were distributed worldwide, including throughout all U.S. states and territories and internationally to countries including Canada, Australia, France, Germany, Japan, India, and others. The product codes affected are 254500503, 254500504, 254500505, 254500506, 254500507, and 254500508. The source document does not specify a remedy or what affected 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: 34676 units Lot/code info: Product Codes: 254500503, 254500504, 254500505, 254500506, 254500507, and 254500508. GTIN: 10603295132431, 10603295132448, 10603295132455, 10603295132462, 10603295132479, and 10603295132486.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.