The Instructions For Use for the following: Stryker recall: Sterility Concern
The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW Stryker TRIO+…
Why was The Instructions For Use for the following: Stryker recalled?
The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a "Sterile" logo in the lower right corner. The products these IFUs were packed with are sold as "Non-Sterile" and require sterilization before use in surgery.
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 information listed in the following format: Manufacturer Part Number/Prodcut Description/Corresponding IFU Part Number/Affected Lot #s are as follows: 48900445/Trio Standard Post Screw 5.5x55mm/#NOLI135B03Rev02/57281 and 57201 48900450/Trio Standard Post Screw 5.5x60mm/#NOLI135B03Rev02/57197 48900455/Trio Standard Post Screw 4.5x45mm/#NOLI135B03Rev02/57198 48900555/Trio Standard Post Screw 4.5x50mm/#NOLI135B03Rev02/56599 48900560/Trio Standard Post Screw 4.5x55mm/#NOLI135B03Rev02/57192
- Product
- The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW Stryker TRIO+…
- Recalling firm
- Stryker Spine
- Quantity
- 40 units.
- Distribution
- Distributed in Atlanta, Georgia.
- Recall date
- August 29, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)