Ortho-implant Surgical Pack recall
ORTHO-IMPLANT SURGICAL PACK, Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…
Why was Ortho-implant Surgical Pack recalled?
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Code:900741A Lots: 140915516 exp. 11/30/15 150116509 exp. 12/31/15 150116510 exp. 12/31/15 150317657 exp. 3/31/16 150318094 exp. 3/31/16 150318095 exp. 3/31/16 150318197 exp. 4/30/16 150318196 exp. 4/30/16 150318198 exp. 4/30/15 150518839 exp. 5/31/16 150619189 exp. 6/30/16 150619406 exp. 6/30/16
- Product
- ORTHO-IMPLANT SURGICAL PACK, Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…
- Recalling firm
- Customed, Inc
- Quantity
- 639
- Distribution
- Distributed Only in Puerto Rico.
- Recall date
- September 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)