FDA Device recall Z-0532-2013
Medline Total Knee CDS
- FDA Device
- Class II
- terminated
- Published 2012-12-26
On 2012-12-26 the FDA classified a Class II recall of Medline Total Knee CDS by Medline Industries, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0532-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-20 |
| Published | 2012-12-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medline Industries |
| Distribution | US |
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.
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.
Identifiers
| code_info | Reorder #CDS983828, lot numbers 12HD0901 and 12IB1848, expiration date 09/30/2013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0532-2013%22
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