Zimmer Orthopaedic Surgical Products Pulsavac Plus AC Component Kit, Catalog #00-5150-426-01, 1 kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pulsavac Plus AC Component Kit, Catalog #00-5150-426-01, 1 kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
Brand
Zimmer Orthopaedic Surgical Products
Lot Codes / Batch Numbers
Lot Numbers: 60622533, 60642558, 60654878, 60656842, 60693312, and 60725489
Products Sold
Lot Numbers: 60622533, 60642558, 60654878, 60656842, 60693312, and 60725489
Zimmer Orthopaedic Surgical Products is recalling Pulsavac Plus AC Component Kit, Catalog #00-5150-426-01, 1 kit/package, Zimmer Orthopaedic Surgica due to Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.
Recommended Action
Per FDA guidance
Zimmer notified their customers via an Urgent Device Recall letter dated January 8, 2008. The letter requests each customers to inventory their stock. If any recalled product is located the customer is to notify Zimmer via fax and a replacement part will be shipped to them.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026