Medline Total Knee CDS — Class II medical device recall Z-0532-2013
Terminated recall by Medline Industries Inc, reported 2012-12-26, distributed nationwide. The Back Table Cover component in the custom pack was placed in the non-sterile portion of the pack when it sh
| Recall number | Z-0532-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries Inc, Mundelein, IL, United States |
| Recall initiated | 2012-09-20 |
| Classified | 2012-12-17 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2012-12-17 |
| Distributed | Nationwide (US) |
| Quantity | 18 packages |
| Reason classes | sterility |
| Lot numbers | 12HD0901, 12IB1848 |
| Expiration dates | 2013-09-30 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0532-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.