Z-2636-2020Class II
EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 -
Skeletal Kinetics, LLC / initiated 2020-04-06 / Terminated / root cause: labeling and UDI
Skeletal Kinetics, Llc began a recall of EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal... on . FDA classified it as Class II and gives the reason as "Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health...". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-2636-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Skeletal Kinetics, LLC
- Product
- EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
- Product code
- MQV Filler, Bone Void, Calcium Compound
- Reason for recall
- Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
- Root cause tag
- labeling and UDI
- FDA root cause
- Under Investigation by firm
- Action
- On 04/06/2020, the firmed notified affected customers via email and/or facsimile of "URGENT Medical Device Recall" letter. The letter indicated actions to be taken by the customers and Clinical Providers. For affected customers, the firm is requesting that affected customers: (1) review this letter in full, review current inventory, and complete and return the "Acknowledgement and Receipt Form" via email, [email protected]; and (2) return unused inventory via Federal Express with reference to Return Material Authorization. If you have further distributed any of the affected devices to other subaccounts, please communicate this recall information immediately and conduct a sub-recall to those accounts. Please request that they immediately cease distribution of the affected devices and promptly return the product to you. Subsequently, contact the firm for instructions on returning the recalled product you receive from your subaccounts. For affected Health Care Providers, the firm is requesting the following: For any patient that may have been implanted with recalled product, we recommend that healthcare providers use judgement regarding patient follow-up. If the patient shows signs of incomplete bone formation or lack of bone formation, delayed union, or nonunion, the appropriate clinical measures should be taken based on the individual patient circumstances. If the patient experienced adequate healing, there is no reason to believe that there would be any additional concerns with the product. Report any adverse health consequences or quality problems experienced with the use of the product to the firm at 972-677-4600. For questions regarding the recall, contact the firm via email at [email protected].
- Quantity in commerce
- 60
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, CA, CO, FL, IL, MO, MS, OH, OK, OR, TN, TX, WI and the countries of Australia, Canada, South Africa, Switzerland.
- Product codes and lots
- Lot Number: 17081106, 17120617.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2592-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2593-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2594-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2595-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2596-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2597-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2598-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2599-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2600-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2601-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2602-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2603-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2604-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2605-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2606-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2607-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2608-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2609-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2610-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2611-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2612-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2613-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2614-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2615-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2616-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2617-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2618-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2619-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2620-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2621-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2622-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2623-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2624-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2625-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2626-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2627-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2628-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2629-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2630-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2631-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2632-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2633-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2634-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2635-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2636-2020 | Class II | Terminated | Voluntary: Firm initiated |
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