Z-0532-2013 Class II Terminated
FDA device recall Z-0532-2013 was initiated by Medline Industries Inc on Sep 20, 2012 and is designated Class II. 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. The recall status is terminated (terminated Dec 17, 2012). Affected quantity: 18 packs.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 26, 2012
- Initiation Date
- Sep 20, 2012
- Termination Date
- Dec 17, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 packs
Product Description
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.
Distribution Pattern
US (nationwide) in the state of West Virginia
Code Information
Reorder #CDS983828, lot numbers 12HD0901 and 12IB1848, expiration date 09/30/2013
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0532-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026