GIZA Vertebral Body Replacement
Check against the official notice below — it lists the full affected range.
Eden Spine Europe SA is recalling 1,839 GIZA Vertebral Body Replacement implants distributed across the United States because surgeons have reported that the locking screws on these devices can unscrew completely, causing the implants to disassemble. The affected implants include six specific part numbers and variations of the Cage Giza with 14mm diameter in different heights and angles, distributed to healthcare facilities in 40 states plus Washington, D.C.
The recall affects implants with part numbers 48291482S, 48291485S, 48291422S, 48291427S, 48291432S, and 48291437S. The source document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw.
Reason for recall: Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw. Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WY Quantity: 1,839 Lot/code info: Part # 48291482S Cage Giza Diam 14mm, 18-22 mm, 2-5 Deg GTIN 07640167930012 Part # 48291485S Cage Giza Diam 14mm, 18-22 mm, 5-8Deg GTIN 07640167930029 Part # 48291422S Cage Giza Diam 14mm, 23-32 mm, 2-5 Deg GTIN 07640167930036 Part # 48291427S Cage Giza Diam 14mm, 23-32 mm, 7-10 Deg GTIN 07640167930043 Part # 48291432S Cage Giza Diam 14mm, 33-54 mm, 2-5 Deg GTIN 07640167930050 and Part # 48291437S Cage Giza Diam 14mm, 33-54 mm, 7-10 Deg GTIN 07640167930067
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.