Eden Spine GIZA Vertebral Body Replacement Recalled Due to Locking Screw Failure
Eden Spine Europe SA is recalling GIZA Vertebral Body Replacement devices because locking screws may unscrew completely, causing the implants to disassemble.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical failure risk (disassembly) that poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Eden Spine Europe SA is recalling 1,839 units of the GIZA Vertebral Body Replacement. The recall was initiated after complaints that surgeons had to disassemble the implants because the locking screws unscrewed completely.
The affected devices include specific part numbers for Cage Giza Diam 14mm in various sizes and angles. The products were distributed to 40 states and the District of Columbia, including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WY.
Consumers and healthcare providers should contact Eden Spine Europe SA for further instructions regarding the recall and potential replacement or repair of the affected devices.
The recalled product
- Product
- GIZA Vertebral Body Replacement
- Manufacturer
- Eden Spine Europe SA
- Affected units
- 1,839
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Part # 48291482S Cage Giza Diam 14mm
- 18-22 mm
- 2-5 Deg GTIN 07640167930012 Part # 48291485S Cage Giza Diam 14mm
- 5-8Deg GTIN 07640167930029 Part # 48291422S Cage Giza Diam 14mm
- 23-32 mm
- 2-5 Deg GTIN 07640167930036 Part # 48291427S Cage Giza Diam 14mm
- 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
- 7-10 Deg GTIN 07640167930067
Distribution
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