Nobel Biocare N1 TiUltra TCC NP 3.5x13mm

FDA device recall Z-1565-2022 · posted 2022-08-23 · Open, Classified

Recall details

Recalling firm

Nobel Biocare

Reason for recall

Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.

Action taken

On 07/25/2022, Nobel Biocare AB sent an "URGENT MEDICAL DEVICE RECALL" Letter via UPS to customers informing them that there may be a burr present on the co-packed OsseoShaper 1 around the waist of the device. The hazard is primarily identified as a risk of the patient swallowing or inhaling the burr if it comes loose from the OsseoShaper 1 during the clinical procedure. Customer are instructed to: 1. Inspect their stock and quarantine affected devices. 2. Complete attached Customer Acknowledgment Form, even if they do not have any affected stock, and return it to Nobel Biocare, via email to us.cs.complaints@nobelbiocare.com or fax 714-282-5073 within 5 days of receipt of this notice. 3. Return all affected stock on hand to Nobel Biocare using the shipping label attached to this notice. 4. Ensure relevant staff members are informed of this recall. If they have supplied or transferred any potentially affected product to another facility or organization, let that facility know of the recall by providing a copy of this notice. Nobel Biocare has implemented preventive actions and will replace devices subject to this recall free of charge. For questions - contact local customer support representative at 800-322-5001 ext. 1527.

Root cause

Process change control

Status

Open, Classified

Product code

DZE

Quantity affected

347 devices

Distribution

U.S Nationwide.: AZ, CA, CT, FL, HI, NC, NY, OR, PA, TX, UT, and WI O.U.S.: Austria, Belgium, Canada, Germany, Spain, France, United Kingdom, Hungary, Iceland, Italy, Netherlands, Norway, Portugal, an

Date initiated

2022-07-25

Date posted

2022-08-23

Location

Goteborg, Sweden

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