BiMobile UHMWPE Liner: ID-28mm/OD-54mm recall: Labeling Error
BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients with…
Why was BiMobile UHMWPE Liner: ID-28mm/OD-54mm recalled?
The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
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?
Lot# 1707116
- Product
- BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients with…
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Quantity
- 31
- Distribution
- US distribution to states of: AZ, FL, GA, LA, MI, MN, TX, and WA.
- Recall date
- January 23, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)