S-Rom¿ Total Hip System Poly Liner Packaging: The recall
S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch…
Why was S-Rom¿ Total Hip System Poly Liner Packaging: The recalled?
Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of four lots of the S-ROM" liner because the Carton label has an Incorrect Color Code Series Designation. We have received one complaint regarding this issue.
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?
Catalogue Lot Number 87-5987 3189424 3312166 3340992 3402685
- Product
- S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch…
- Recalling firm
- DePuy Orthopaedics, Inc.
- Quantity
- 12 liners
- Distribution
- Nationwide Distribution including the states of MA, TX, OH, CA, and NC.
- Recall date
- September 26, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)