FDA Medical Device Recalls (openFDA)
Alto Development Corp: A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.
- Recall number
- Z-0244-2020
- Recalling firm
- Alto Development Corp
- Product
- A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.
- Status
- Terminated
- Initiated
- 2019-09-10
- Posted
- not on file
- Terminated
- 2020-05-12
- Reason
- Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.
- Root cause
- Process control
- Action
- On September 10, 2019, the firm distributed a letter to customers titled Product Recall: Action Required. The letter informed customers of the potential tensioner failure. Customers were given two options: 1. A&E will provide a supply of individually packaged, sterile tensioners to be kept on hand should a kit tensioner be found inoperable. Surgeons and Operating Room staff need to be alerted to this situation and the stock of additional tensioners readily available to them during surgery. 2. For those customers who prefer to return their affected lots of Thorecon, A&E will provide a Returned Goods Authorization and replacement product (to be provided as soon as inventory is available). Any failed tensioners can be discarded. Customers were asked to complete and return the acknowledgement form included with the mailing. Should you have any questions about the action or the product, please contact your A&E Sales Representative or our Customer Service at 800-323-4035.
- Quantity
- 209 total
- Distribution
- Distributed to AL, CA, FL, GA, IL, LA, MO, OK, MS, NM, OK, SC, TX, UT, VT, WA, and WI.
- Lot, serial or model codes
- 327705, 327706, 330587, 330588, 330753, 334396, 345417, 345418
- 510(k) numbers
- ["K181607"]
- PMA numbers
- not on file
- Product code
- JDQ
- Firm FEI
- 2242056
- Firm city
- Wall Township
- Firm state
- NJ
- 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