FDA Medical Device Recalls (openFDA)
Synthes USA HQ, Inc.: Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.
- Recall number
- Z-1952-2013
- Recalling firm
- Synthes USA HQ, Inc.
- Product
- Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.
- Status
- Terminated
- Initiated
- 2013-06-11
- Posted
- 2013-08-12
- Terminated
- 2015-08-31
- Reason
- Due to the coiled design for this product, the product is difficult to clean and the potential for corrosion on the device exists. The potential for harm exists if there is an introduction of foreign material at the operative site originating from the presence of corrosion and/or the retained undefined material that could not be adequately cleaned.
- Root cause
- Device Design
- Action
- Sythes notified direct accounts by letter on 6/11/13 and requested them to check their inventory and remove affected lots from stock. Synthes requested that affected lots be returned and to call Synthes at 1-800-479-6329 for a Return Authorization Number. Completion and return of the Verification section at the end of the letter was requested, including negative responses.
- Quantity
- 13,050
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- All lots with part number 359.106, 359.107, 359.108, 359.109, 359.110, 359.111, 359.112, 359.113, 359.114, 359.115
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTO
- Firm FEI
- 3005180112
- 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