A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.
Recall
- Recall Number
- Z-0243-2020
- Event Number
- 83942
- Firm
- Alto Development Corp
- FEI Number
- 2242056
- Product Code
- JDQ
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- September 10, 2019
- Terminated
- May 12, 2020
- Address
- 5206 Asbury Rd, Wall Township, NJ, 07727-3609
Description
A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.
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.
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.
Distributed to AL, CA, FL, GA, IL, LA, MO, OK, MS, NM, OK, SC, TX, UT, VT, WA, and WI.
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