Zimmer Surgical Inc: Medical Device Recall in 2015 - (Recall #: Z-1610-2015)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2015.
Data Source: FDA.
Product Description:
Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.
Product Classification:
Class III
Date Initiated: April 21, 2015
Date Posted: May 20, 2015
Recall Number: Z-1610-2015
Event ID: 71057
Reason for Recall:
Devices were placed in a shipper carton without the appropriate number of the Instructions for Use (IFU). Packaging specifications require that each sales unit is accompanied by an IFU. Only one IFU was present in the shipper carton, instead of one IFU per each of the two sales units.
Status: Terminated
Product Quantity: 36 units
Code Information:
Item #00-2568-000-10; Lot #62800843
Distribution Pattern:
Worldwide Distribution -- US, including the states of AZ, CA, ID, IL, MD, NC, RI, and SC; and, Canada.
Voluntary or Mandated:
Voluntary: Firm initiated