Recall Z-0970-2015
Stelkast Co · initiated December 1, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
Codes / lots: part numbers SC3425 and SC3453, with lot numbers:28592-103112 28593-102412 28602-110112 28603-110112 28613-110112 28617-110112 28618-110112 28622-112812 28623-112812 28624-112812 31031-121013 31033-121013 31040-121013 31249-022514 31261-020414 28592-103112 28593-102412 28598-111412 28599-111412 28602-110112 28603-110112 28607-111912 28613-110112 28617-110112 28618-110112 28622-112812 28623-112812 28624-112812 31029-120913 31040-121013 31043-120913 31243-022414 31244-022414 31249-022514 31252-021314 31255-020414 31261-020414 32083-080714 31028-120913 31031-121013 31032-121013 31033-121013 31042-121013 31044-120913 31243-022414 31244-022414 31245-022414 31252-021314 31255-020414 31261-020414 31263-021314 31264-031114 31265-031114 31266-031114 28592-103112 28593-102412 28598-111412 28599-111412 28602-110112 28603-110112 28607-111912 28613-110112 28617-110112 28618-110112 28622-112812 28623-112812 28624-112812 31029-120913 31034-120913 31040-121013 31043-120913 31044-120913 31249-022514 31255-020414 32083-080714 28592-103112 28593-102412 28598-111412 28599-111412 28602-110112 28603-110112 28607-111912 28613-110112 28617-110112 28618-110112 28622-112812 28623-112812 28624-112812…
Reason for recall
Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of this lead in may prevent or make assembly of the insert and tray difficult.
FDA-determined cause: Process design
Action taken
On December 1, 2014, phone calls were made to all direct accounts to notify them of the recall and to request immediate recovery and return of the SC3425 EXp PS Tibial Tray Inserts and SC3453 EXp CR-HF Inserts from their inventory.
Details
- Recall number
- Z-0970-2015
- Initiated
- December 1, 2014
- Posted by FDA
- January 14, 2015
- Terminated
- May 6, 2015
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Quantity
- 553
- Distribution
- TX, MD, IN, KS, CA, PA, GA, WA, NY, IL.
- Recalling firm
- Stelkast Co, Mcmurray, PA