Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item No. 00585001202); c. Size C-LT (Item No. 00585001301); d. Size C-RT (Item No. 00585001302) Components of the system are intended to replace the proximal femur, mid-shaft femur, distal
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is recalling 3,350 units of its Zimmer Segmental System, ZSS Distal Femur in multiple sizes (B-LT, B-RT, C-LT, and C-RT). The products exceeded the weight that was previously tested, which could result in damage to the package and compromise the sterile barrier that protects the medical device. The recalled units have lot expiration dates before July 31, 2026 or August 31, 2026, depending on the specific item number.
The recalled products were distributed worldwide, including throughout the United States in all 50 states plus Puerto Rico and Washington D.C., as well as to multiple countries including Canada, Australia, Brazil, China, France, Germany, Japan, and others. The source document does not specify a remedy or course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.
Reason for recall: The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier. Distribution: Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico; and to countries of: Austria, Australia, Bahamas, Brazil, Canada, China, Dominican Republic, England, France, Germany, Israel, Jap Quantity: 3,350 units total Lot/code info: a. Item No. 00585001201 (Lot Expiration Date Before 07/31/2026); b. Item No. 00585001202 (Lot Expiration Date Before 07/31/2026); c. Item No. 00585001301 (Lot Expiration Date Before 08/31/2026); d. Item No. 00585001302 (Lot Expiration Date Before 07/31/2026)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.