FDA Medical Device Recalls (openFDA)
DePuy Spine, Inc.: EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467
- Recall number
- Z-1674-2015
- Recalling firm
- DePuy Spine, Inc.
- Product
- EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467
- Status
- Terminated
- Initiated
- 2015-04-21
- Posted
- 2015-05-26
- Terminated
- 2018-10-03
- Reason
- Device does not mate as intended.
- Root cause
- Process design
- Action
- Consignees were notified of the recall via letter sent by overnight shipment for delivery on April 23, 2015. The letter instructs distributors and customers to review their inventory and return any products with the listed lot number.
- Quantity
- 183 devices
- Distribution
- US: PA and OUS: SE, BE, IT, PT
- Lot, serial or model codes
- LOT NUMBER: ARNDC6 & ARN DC7
- 510(k) numbers
- ["K101070","K111136","K142460"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 1526439
- Firm city
- Raynham
- Firm state
- MA
- 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