ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 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 p
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics has recalled 13,964 units of ATTUNE Knee Tibial Articulation Surface trial instruments in sizes 1, 2, 9, and 10 distributed worldwide, including throughout the United States and internationally to Canada, Australia, Austria, Belgium, England, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, and Japan. The recalled product is identified by product codes 254500981, 254500982, 254501989, and 254501990, with corresponding GTINs. These instruments are trial components used during knee replacement surgery.
The recall was initiated because a small wire spring coil called a Balseal, located on the post feature of the instrument, can become damaged and separate from the post. If the Balseal disassociates during surgery without the surgeon's awareness, it could potentially remain in the patient's surgical site. The recall record does not specify a remedy or recommended 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: 13964 units Lot/code info: Product Codes:254500981, 254500982, 254501989, and 254501990. GTIN: 10603295135586, 10603295135593, 10603295423492, and 10603295423959.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.