FDA Medical Device Recalls (openFDA)
EXP Pharmaceutical Services Corp: Medical Device Exchange Round Diamond Bur Extra Coarse; 3.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-130; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
- Recall number
- Z-2239-2015
- Recalling firm
- EXP Pharmaceutical Services Corp
- Product
- Medical Device Exchange Round Diamond Bur Extra Coarse; 3.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-130; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
- Status
- Terminated
- Initiated
- 2015-02-11
- Posted
- 2015-07-24
- Terminated
- 2015-12-30
- Reason
- EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
- Root cause
- Other
- Action
- EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014. A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
- Quantity
- 2
- Distribution
- Distributed in DC and the states of CO, CA, FL, TX, and AR.
- Lot, serial or model codes
- OEM Catalog number 5820-10-130.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HBE
- Firm FEI
- 3004376386
- Firm city
- Fremont
- Firm state
- CA
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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