FDA Medical Device Recalls (openFDA)
Synthes (USA) Products LLC: Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
- Recall number
- Z-0681-2017
- Recalling firm
- Synthes (USA) Products LLC
- Product
- Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
- Status
- Terminated
- Initiated
- 2016-11-01
- Posted
- 2016-12-01
- Terminated
- 2017-06-01
- Reason
- Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit.
- Root cause
- Under Investigation by firm
- Action
- DePuy Synthes sent an Urgent Notice to customers affected by the recall to inform them of the potential impacts, and actions to be taken for the return of the identified units.
- Quantity
- 84 units
- Distribution
- Distributed Nationwide
- Lot, serial or model codes
- Model/Catalog # 316.15 Lot/Serial Number U172728
- 510(k) numbers
- ["K043310"]
- PMA numbers
- not on file
- Product code
- HWE
- 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