NSTRIDE APS KIT WITH ACD-A
Received Feb 23, 2026 · Event occurred Jan 23, 2026
Report 0001825034-2026-00411 · MDR key 24414720
Device
Generic name
Supplies, Blood-bank
Manufacturer
Zimmer Biomet, Inc.Catalog number
800-3000ST
Lot number
0214184
Product problems
- Device Contaminated During Manufacture or Shipping
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). D2: A. COMMON DEVICE NAME, PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING. B. DEVICE PRODUCT CODE, ORG. E1: ADDRESS, (B)(6). G2: FOREIGN, EVENT OCCURRED IN (B)(6). THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT DURING ROUTINE UNPACKING, A FOREIGN OBJECT IDENTIFIED AS HAIR WAS FOUND INSIDE A SEALED DEVICE BOX. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.