TMJ Components (Endotec) - Sterility Issues (2009)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TMJ Components: Right Ramus Component - DelCristo Catalog: 09-11-0215, TMJ - Shah Catalog: 09-42-0217, 09-11-0217. Left Fossa Component - DelCristo Catalog 09-42-0216, Left Ramus Component - DelCristo Catalog: 09-11-0216.
Brand
Endotec, Inc.
Lot Codes / Batch Numbers
Lot No: 09110215NN373 09110216NN373 09110217NN379 09420216NN373 09520217NN379
Products Sold
Lot No: 09110215NN373 09110216NN373 09110217NN379 09420216NN373 09520217NN379
Endotec, Inc. is recalling TMJ Components: Right Ramus Component - DelCristo Catalog: 09-11-0215, TMJ - Shah Catalog: 09-42-02 due to Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations a. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.
Recommended Action
Per FDA guidance
Recall Letters were sent to each distributor on 06/07/2009. Questions are directed to Endotec at (407) 822-0021.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, IN, NJ, OH, TN, TX
Page updated: Jan 10, 2026