ImplantDirect Legacy(TM) 3 Implant recall
ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures.…
Why was ImplantDirect Legacy(TM) 3 Implant recalled?
One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not be screwed on properly and the sterilization compromised.
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 Number: 79607
- Product
- ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures.…
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Quantity
- 75 units
- Distribution
- Worldwide distribution: US (nationwide) including Puerto Rico and country of Japan.
- Recall date
- December 6, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)