Recall Z-2456-2023
Medicrea International · initiated July 12, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i) B20181953, j) B20181963, k) B20181973, l) B20182253, m) B20182263; intervertebral fusion device - lumbar
Codes / lots: a) A20150407, GTIN 03613720236016, Lot Numbers: 18F0803, 18J0713, 18J0714, 19A0225, 19A0786, 19A0787, 19D0381, 19D0382, 19J0594, 20A0280, 20H0285, 20I0475, 20K0424, 21D0442, 21I0596, 22E0637; b) A20250407, GTIN 03613720236078, Lot Numbers: 18E0532, 18I0840, 18I0841, 18K0067, 18K0068, 18L0399, 19A0371, 19A0372, 19C0587, 19D0383, 19D0384, 19J0592, 19J0746, 19K0731, 19K0853, 20A0281, 20C0260, 20F0920, 20H0286, 20I0476, 20J0558, 20K0425, 21D0858, 21F0990, 21I0598, 22C0262, 22C0268, 22D0732, 22E0638, 22E0640, 22E0642, 22E0656, 22F0408, 22F0409; c) A20350567, GTIN 03613720236108, Lot Numbers: 18K0069, 19B0752, 19D0745, 20A0279, 20F0922, 20I0477, 21D0443, 21G0784, 22D0733, 22G0683; d) B20181743, GTIN 03613720233251, Lot Numbers: 19D0208, 19E0604, 19K0588; e) B20181753, GTIN 03613720233275, Lot Numbers: 20G0209, 20I0486, 20L0199, 21C0843; f) B20181763, GTIN 03613720233305, Lot Numbers: 18L0570, 19D0100, 19G0205, 19J0470, 20A0645; g) B20181773, GTIN 03613720233336, Lot Numbers: 19A0830, 19J0611, 19L0612, 20I0831; h) B20181943, GTIN 03613720233442, Lot Numbers: 19K0878, 20E0094, 21G0420; i) B20181953, GTIN 03613720233466, Lot Numbers: 21K0501; j) B20181963, GTIN 03613720233497, Lot…
Reason for recall
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
FDA-determined cause: Under Investigation by firm
Action taken
Beginning 12 July 2023, In the U.S. Medtronic disseminated an URGENT: MEDICAL PRODUCT RECALL to its consignees via UPS 2-Day delivery. The notice explained the problem, risk, and requested the following: Medtronic requests that you immediately take the following actions: Identify and quarantine any unused impacted product(s). Return all unused and non-expired product(s) in your inventory to Medtronic following the instructions in the enclosed Customer Confirmation Form. Your Medtronic Sales Representative can assist in returning any affected consignment and loaner inventory, if applicable. Complete the Customer Confirmation Form enclosed with this letter (even if you have no product to return), acknowledging that you have received this information. This notice should be distributed to all others in your organization who should be aware, or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records.
Details
- Recall number
- Z-2456-2023
- Initiated
- July 12, 2023
- Posted by FDA
- August 24, 2023
- Product code
- ODP – Intervertebral Fusion Device With Bone Graft, Cervical
- Quantity
- 4489 units
- Distribution
- US nationwide
- Recalling firm
- Medicrea International, Vancia Vancia Rillieux La Pape
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2452-2023 Class II | IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… | 07/12/2023Open, Classified |
| Z-2453-2023 Class II | IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… | 07/12/2023Open, Classified |
| Z-2454-2023 Class II | IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbarThere is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… | 07/12/2023Open, Classified |
| Z-2455-2023 Class II | IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… | 07/12/2023Open, Classified |
| Z-2457-2023 Class II | IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… | 07/12/2023Open, Classified |
| Z-2458-2023 Class II | PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… | 07/12/2023Open, Classified |
| Z-2459-2023 Class II | GRANVIA-C, REF numbers: a) A13111427, b) A13112567, c) A13113456, d) A13131516, e)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… | 07/12/2023Open, Classified |
| Z-2460-2023 Class II | IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… | 07/12/2023Open, Classified |
| Z-2461-2023 Class II | IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… | 07/12/2023Open, Classified |
| Z-2462-2023 Class II | IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… | 07/12/2023Open, Classified |