Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326
FDA Recall Z-1926-2020 · Posted None
Recalling FirmStryker Corporation
Recall StatusOpen, Classified
Product CodeMMP
Date Initiated2020-01-07
Product Quantity21,078 units
Reason for Recall
Sterile drapes packaged in an unsealed pouch.
Firm Action
An URGENT MEDICAL DEVICE RECALL NOTIFICATION letter was sent to the affected customers on 01/07/2020 informing them of the product field action prompting them to send any unused affected units back to the manufacturer.
Root Cause
Under Investigation by firm
Distribution Pattern
US - Nationwide & Puerto Rico OUS - Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan, Puerto Rico, South Africa, South Korea, Australia, Chile, China, Germany, France, United Kingdom, Hong Kong, India, Italy, Singapore, Thailand, Romania, Belgium, Sweden, Switzerland, Austria, Malaysia, Finland, Denmark, Israel, Qatar, Kazakhstan, Turkey, Czech Republic, Greece, Russia, Poland, Ireland, Philippines, and New Zealand.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.