ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 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 con
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics, Inc. has recalled 11,360 units of ATTUNE Knee Tibial Articulation Surface Instruments used during knee surgery trials. The recalled products have product codes 254500991 through 254500999. 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 becomes separated from the post, it could enter the surgical site and potentially be left inside the patient if the surgeon does not notice the separation. The recall affects products distributed worldwide, including all U.S. states and territories and multiple international countries including Canada, Australia, and countries throughout Europe and Asia. The source document does not specify a remedy 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: 11360 units Lot/code info: Product Codes:254500991, 254500992, 254500993, 254500994, 254500995, 254500996, 254500997, 254500998, and 254500999. GTIN: 10603295135685, 10603295135692, 10603295135708, 10603295135715, 10603295135722, 10603295135739, 10603295135746, 10603295135753, and 10603295135760.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.