FDA Medical Device Recalls (openFDA)
Synthes USA HQ, Inc.: Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.
- Recall number
- Z-1062-2013
- Recalling firm
- Synthes USA HQ, Inc.
- Product
- Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.
- Status
- Terminated
- Initiated
- 2013-01-11
- Posted
- 2013-04-05
- Terminated
- 2015-08-31
- Reason
- Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part of the Universal Nail System, due to the potential lack of the ability to thoroughly clean the instrument.
- Root cause
- Device Design
- Action
- Synthes sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" dated January 11, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter requested consignees examine inventory, remove the recalled products from use and return them to Synthes. If you have any questions, contact the firm at 610-719-5450.
- Quantity
- 328
- Distribution
- Nationwide Distribution including the states of AZ, CA, CO, FL, IA, ID, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, PA, RI, TN, TX, UT, VT, WA, WI, and WV.
- Lot, serial or model codes
- Part number 355.28, all lot numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- 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