Recall StatusTerminated
Date Initiated2018-06-22
Date Terminated2019-07-08
Product Quantity22,831 total
Reason for Recall
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Firm Action
URGENT MEDICAL DEVICE RECALL letters dated 6/22/18 were sent to customers with the following requested actions to be taken:
1. Please inform users of this Medical Device Removal and pass this notice to all appropriate
individuals within your organization.
2. Return all affected products available at your location to:
Stryker CMF
Attn: Recall Coordinator
6300 Sprinkle Rd
Portage, MI 49002
REF: PFA #1739180
Or, Contact Stryker Customer Service and refer to PFA #1739180 with any questions about returning the product to us.
3. Complete and sign the enclosed Business Reply Form and fax a copy to: (877) 648-7114 or email a copy to
[email protected].
4. Keep a copy of the completed and executed Customer response Form for your records.
Root Cause
Package design/selection
Distribution Pattern
US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
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.