FDA Medical Device Recalls (openFDA)
Synthes (USA) Products LLC: 2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
- Recall number
- Z-0643-2017
- Recalling firm
- Synthes (USA) Products LLC
- Product
- 2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
- Status
- Terminated
- Initiated
- 2016-10-03
- Posted
- 2016-11-19
- Terminated
- 2017-07-06
- Reason
- The peel pouches for the affected reaming rods and extraction hooks are delaminating.
- Root cause
- Nonconforming Material/Component
- Action
- DePuy Synthes mailed a Customer Safety Advisory Notice on October 19, 2016 to affected customers advising them of the malfunction, potential risks and the actions needed to be taken to avoid injury, as they work on a solution to correct the problem.
- Quantity
- 260 units
- Distribution
- Distributed Nationwide
- Lot, serial or model codes
- Catalog ID 359.083S, Lot Numbers: H115566; H116597; H116601; H117049
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTO
- 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