FDA Medical Device Recalls (openFDA)
Brasseler USA I Lp: Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
- Recall number
- Z-1008-2024
- Recalling firm
- Brasseler USA I Lp
- Product
- Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
- Status
- Open, Classified
- Initiated
- 2024-01-11
- Posted
- 2024-02-07
- Terminated
- not on file
- Reason
- The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.
- Root cause
- Under Investigation by firm
- Action
- The recalling firm issued letters dated 1/8/2024 on 1/11/2024 via certified mail. The letter explains the reason for recall and required customer actions. The actions included that upon receipt of the letter, confirm the quantity of unused recalled product in their inventory and set it aside for return. Return information will be emailed to the consignee with a return label. The Customer Service emailed the letters to consignees on 1/12/2024 and sent product return instructions in the email. Phone calls will be made on 1/16/2024 if no response if received from the consignee via email. The recalling firm will be recording the amount of product to be returned on the phone log which will be completed for every consignee contacted. During the call, the consignees will also be given the product return instructions.
- Quantity
- 440 burs
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, CA, CO, DC, IL, NY, OH, OR, PA, TN, TX, and WA. The country of Canada.
- Lot, serial or model codes
- Lot numbers L01G6 and L16P9, UDI-DI 00887919188483, RX.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EJL
- Firm FEI
- 1032227
- Firm city
- Savannah
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28