Z-2461-2023Class II
IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f)...
Medicrea International / initiated 2023-07-12 / Open, Classified / root cause: packaging
Medicrea International began a recall of IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical on . FDA classified it as Class II and gives the reason as "There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch". As of , the recall status on record is Open, Classified, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-2461-2023
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Medicrea International
- Product
- IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical
- Product code
- MAX Intervertebral Fusion Device With Bone Graft, Lumbar
- 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.
- Root cause tag
- packaging
- FDA root cause
- Under Investigation by firm
- Action
- 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.
- Quantity in commerce
- 0 (US)
- Distribution
- US nationwide
- Product codes and lots
- a) B15328071S, GTIN 03613720195535, Lot Numbers: 19I0696, 20A0759; b) B15328073S, GTIN 03613720195573, Lot Numbers: 20B0747; c) B15328074S, GTIN 03613720195597, Lot Numbers: 19I0698; d) B15334072S, GTIN 03613720195832, Lot Numbers: 19I0557, 20F0185; e) B15334073S, GTIN 03613720195856, Lot Numbers: 19J0947; f) B15334074S, GTIN 03613720195870, Lot Numbers: 19E0502, 19J0091, 20F0184
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2452-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2453-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2454-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2455-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2456-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2457-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2458-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2459-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2460-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2461-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2462-2023 | Class II | Ongoing | Voluntary: Firm initiated |
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