Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly

FDA device recall Z-1157-2020 · posted 2020-02-05 · Terminated

Recall details

Recalling firm

Implant Direct Sybron Manufacturing LLC

Reason for recall

Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new surgical procedures to place the correct parts. The level of severity varies based on a one or two stage surgery.

Action taken

On October 11, 2019 the firm sent an "URGENT: MEDICAL DEVICE RECALL" letter via FedEx overnight priority mail. The letter advised the consignees of the recall. In addition, the letter states: We request that you take the following actions immediately:. 1. Please review your inventory for the affected product. If located, please quarantine the affected product and return the product to us according to the instructions on the attached form. 2. Please complete and return the Acknowledgement Form within fortyeight (48) hours of receipt of this notification, whether you have affected product or not. 3. If you are an authorized Implant Direct Sybron Manufacturing LLC distributor, we request that you identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hours of receipt of this notification. 4. If you have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425. Customer Care is available Monday through Friday, between the hours of 5am-5pm PST. If you or your patients have experienced any issues as a result of the affected products noted in this URGENT: MEDICAL DEVICE RECALL HHE 855710 100419 Rev 01 Status: RELEASED printed 10/10/2019 2:27:23 PM by Jose Trejo www.implantdirect.com | 888-649-6425 communication, you may voluntarily report the incident to the FDA through the MEDWATCH reporting system at the following: http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

DZE

Quantity affected

78 implants

Distribution

US: AR, AZ, CA, ID, IL, IN, KY, MD, ND, NH, NJ, NV, NY, Oh, OR, PA, TX, UT, WA, WI, WV, GA,MO

Date initiated

2019-10-11

Date posted

2020-02-05

Date terminated

2024-04-12

Location

Westlake Village, CA

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