Z-2700-2015Class II
ORTHO-IMPLANT SURGICAL PACK, Used by medical staff to perform surgical procedures and patient care procedures...
Customed, Inc / initiated 2015-07-10 / Terminated / root cause: packaging
Customed, Inc began a recall of ORTHO-IMPLANT SURGICAL PACK, Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate... on . FDA classified it as Class II and gives the reason as "Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-2700-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Customed, Inc
- Product
- ORTHO-IMPLANT SURGICAL PACK, Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
- Product code
- OJH Orthopedic Tray
- Reason for recall
- Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- Root cause tag
- packaging
- FDA root cause
- Packaging
- Action
- Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.
- Quantity in commerce
- 639
- Distribution
- Distributed Only in Puerto Rico.
- Product codes and lots
- Code:900741A Lots: 140915516 exp. 11/30/15 150116509 exp. 12/31/15 150116510 exp. 12/31/15 150317657 exp. 3/31/16 150318094 exp. 3/31/16 150318095 exp. 3/31/16 150318197 exp. 4/30/16 150318196 exp. 4/30/16 150318198 exp. 4/30/15 150518839 exp. 5/31/16 150619189 exp. 6/30/16 150619406 exp. 6/30/16
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2548-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2549-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2550-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2551-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2552-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2553-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2554-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2555-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2556-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2557-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2558-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2559-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2560-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2561-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2562-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2563-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2564-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2565-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2566-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2567-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2568-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2569-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2570-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2571-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2572-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2573-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2574-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2575-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2576-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2577-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2578-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2579-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2580-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2581-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2582-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2583-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2584-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2585-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2586-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2587-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2588-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2589-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2590-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2591-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2592-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2593-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2594-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2595-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2596-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2597-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2598-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2599-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2600-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2601-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2602-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2603-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2604-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2605-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2606-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2607-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2608-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2609-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2610-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2611-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2612-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2613-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2614-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2615-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2616-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2617-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2618-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2619-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2620-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2621-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2622-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2623-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2624-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2625-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2626-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2627-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2628-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2629-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2630-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2631-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2632-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2633-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2634-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2635-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2636-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2637-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2638-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2639-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2640-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2641-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2642-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2643-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2644-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2645-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2646-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2647-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2648-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2649-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2650-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2651-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2652-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2653-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2654-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2655-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2656-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2657-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2658-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2659-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2660-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2661-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2662-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2663-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2664-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2665-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2666-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2667-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2668-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2669-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2670-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2671-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2672-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2673-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2674-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2675-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2676-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2677-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2678-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2679-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2680-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2681-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2682-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2683-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2684-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2685-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2686-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2687-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2688-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2689-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2690-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2691-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2692-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2693-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2694-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2695-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2696-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2697-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2698-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2699-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2700-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2701-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2702-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2703-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2704-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2705-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2706-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2707-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2708-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2709-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2710-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2711-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2712-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2713-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2714-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2715-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2716-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2717-2015 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.