Z-0243-2020Class II

A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of...

Name: Z-0243-2020 A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of...
Creator: Alto Development Corp
Published: 2019-09-10
License: https://open.fda.gov/license/

Alto Development Corp / initiated 2019-09-10 / Terminated / root cause: manufacturing process

FDA source

Alto Development Corp began a recall of A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum on 2019-09-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0243-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-10
Posted: 2019-10-30
Terminated: 2020-05-12
Recalling firm: Alto Development Corp
Product: A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.
Product code: JDQ Cerclage, Fixation
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 209 total
Distribution: Distributed to AL, CA, FL, GA, IL, LA, MO, OK, MS, NM, OK, SC, TX, UT, VT, WA, and WI.
Product codes and lots: 327703, 327704, 330464, 344282

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0243-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0242-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-29
Z-0243-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-29
Z-0244-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-29
Z-0245-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-29
Z-0246-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-29

Product code JDQ

K181607Class IIThorecon Rigid Fixation SystemA & E Medical Corporation / cleared 2018-10-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)