Cobalt HV with Gentamicin recall
Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is…
Why was Cobalt HV with Gentamicin recalled?
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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 Numbers: 189690, 189760, 199180, 424740, 508240, 560290, 595660, 638280, 786630, 959650, 959700
- Product
- Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is…
- Recalling firm
- Encore Medical, Lp
- Quantity
- 9848 units
- Distribution
- Nationwide Distribution
- Recall date
- November 15, 2017
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)