FDA Medical Device Recalls (openFDA)
Synthes USA: Norian Drillable Inject
- Recall number
- Z-0617-2018
- Recalling firm
- Synthes USA
- Product
- Norian Drillable Inject
- Status
- Terminated
- Initiated
- 2017-08-10
- Posted
- not on file
- Terminated
- 2018-09-10
- Reason
- The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.
- Root cause
- Process control
- Action
- On August 15, 2017 an Urgent Medical Device Recall notice, titled "895204 NORIAN DRILLABLE INJECT" was issued to customers instructing them to review inventory and quarantine all affected product subject to the recall. For questions. concerns or to obtain a return authorization Call 1-800-479-6329. Returned product will be credited.
- Quantity
- 239 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Product Number: 07.704.003S Lot Number: DSD9110
- 510(k) numbers
- ["K102722"]
- PMA numbers
- not on file
- Product code
- OIS
- Firm FEI
- 3008812560
- Firm city
- West Chester
- Firm state
- PA
- 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