FDA Medical Device Recalls (openFDA)
Synthes (USA) Products LLC: SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
- Recall number
- Z-0585-2016
- Recalling firm
- Synthes (USA) Products LLC
- Product
- SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
- Status
- Terminated
- Initiated
- 2015-12-01
- Posted
- 2016-01-05
- Terminated
- 2016-08-26
- Reason
- The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm.
- Root cause
- Process design
- Action
- On Dec 1, 2015, Synthes issued a recall notification letter and requested that all consignees review inventory and contact Synthes for a return authorization number. The verification form is to be completed and sent to Stericycle.
- Quantity
- 65
- Distribution
- US nationwide distibution.
- Lot, serial or model codes
- Part number: 352.135; Lot number: F-17180
- 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