FDA Medical Device Recalls (openFDA)
Synthes, Inc.: The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.
- Recall number
- Z-1457-2014
- Recalling firm
- Synthes, Inc.
- Product
- The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.
- Status
- Terminated
- Initiated
- 2014-02-11
- Posted
- 2014-04-15
- Terminated
- 2015-09-10
- Reason
- The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 instead of part number 399.22.
- Root cause
- Error in labeling
- Action
- Synthes sent an Urgent Notice: Medical Device Recall letter dated February 11, 2014, to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to Complete the attached Verification Section form. For questions call 610-719-5450.
- Quantity
- 20
- Distribution
- Worldwide Distribution - USA Nationwide Distribution in the states of: TN, MD, NY, IN, NJ, WA, VA,and the country of Canada.
- Lot, serial or model codes
- part no. 399.24, lot number T974302
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAD
- 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