Z-2997-2017Class II
PALLAS M/MAXIMIS Rod Gauge. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago...
Valorem Surgical / initiated 2017-06-21 / Terminated / root cause: design
Valorem Surgical LLC began a recall of PALLAS M/MAXIMIS Rod Gauge. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation... on . FDA classified it as Class II and gives the reason as "Devices are not consistent with Quality System Requirements". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-2997-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Valorem Surgical
- Product
- PALLAS M/MAXIMIS Rod Gauge. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
- Product code
- MNI Orthosis, Spinal Pedicle Fixation
- Reason for recall
- Devices are not consistent with Quality System Requirements.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- Valorem Surgical sent an Urgent Medical Device Recall letter dated June 21, 2017, informing consignees of the product removal and instructing consignees to return any product to Valorem Surgical LLC to minimize potential risk to patients. Consignees are to fill out the attached Medical Device Recall Return Response form and send it back to the firm by email at [email protected] or by fax at 312-275-7117, or by mail. For questions pertaining to this recall, please submit an email inquiry to [email protected]
- Quantity in commerce
- 262 units total
- Distribution
- Nationwide Distribution - US including CA and VA.
- Product codes and lots
- Catalog No. 0902-1027. Known Lot No. WNV120723.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2873-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2874-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2875-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2876-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2877-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2878-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2879-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2880-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2881-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2882-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2883-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2884-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2885-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2886-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2887-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2888-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2889-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2890-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2891-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2892-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2893-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2894-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2895-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2896-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2897-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2898-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2899-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2900-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2901-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2902-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2903-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2904-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2905-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2906-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2907-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2908-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2909-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2910-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2911-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2912-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2913-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2914-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2915-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2916-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2917-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2918-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2919-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2920-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2921-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2922-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2923-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2924-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2925-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2926-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2927-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2928-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2929-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2930-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2931-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2932-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2933-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2934-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2935-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2936-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2937-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2938-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2939-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2940-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2941-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2942-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2943-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2944-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2945-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2946-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2947-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2948-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2949-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2950-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2951-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2952-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2953-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2954-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2955-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2956-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2957-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2958-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2959-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2960-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2961-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2962-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2963-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2964-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2965-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2966-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2967-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2968-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2969-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2970-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2971-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2972-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2973-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2974-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2975-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2976-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2977-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2978-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2979-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2980-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2981-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2982-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2983-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2984-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2985-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2986-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2987-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2988-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2989-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2990-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2991-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2992-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2993-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2994-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2995-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2996-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2997-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2998-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2999-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3000-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3001-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3002-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3003-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3004-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3005-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3006-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3007-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3008-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3009-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3010-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3011-201 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3012-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3013-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3014-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3015-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3016-2017 | 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.