Device product
Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; Product Usage: This Complete Delivery Systems (CDS) custom pack includes components necessary for a total knee replacement surgical procedure.
Z-0532-2013
Product summary
- Event
- Event 63520
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18 packs
- Official record key
device-enforcement:Z-0532-2013
Official wording
Reason: The Back Table Cover component in the custom pack was placed in the non-sterile portion of the pack when it should have been in the sterile portion.
Code information: Reorder #CDS983828, lot numbers 12HD0901 and 12IB1848, expiration date 09/30/2013
Distribution pattern: US (nationwide) in the state of West Virginia
Derived failure modes
-
Unknown
The Back Table Cover component in the custom pack was placed in the non-sterile portion of the pack when it should have been in the sterile portion.