HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE
FDA Recall Z-0678-2019 · Posted None
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Recalling FirmHowmedica Osteonics Corp.
Recall StatusTerminated
Product CodeMQV
Date Initiated2018-11-15
Date Terminated2020-06-18
Reason for Recall
Incorrect expiry date of 9-Feb-20
Correct expiry date is 30-Aug-19
Firm Action
On November 15, 2018, Stryker issued Urgent Medical Device Recall notices to customers via Fedex. Customers were advised to take the following actions:
1. Inform users of the medical device recall and forward a copy of the notice to all those individuals who need to be aware within the organization.
2. Examine inventory to identify impacted HydroSet kits.
3. Immediately quarantine any affected product.
4. Complete and return the Business Reply Form via email to [email protected] or via fax to 1-888-345-3845.
5. Return all affected product available at your location to the following address:
Stryker Orthopaedics/PFA Product Returns
Attn: Distribution Inventory Team 325 Corporate Drive, Dock M-East, Mahwah, NJ 07431, Ref. PFA 1878253
Root Cause
Labeling mix-ups
Distribution Pattern
CO, FL, GA, IA, MA, ME, MI, MN, NC, ND, NH, NY, PA, SC, TN, TX, VA, WI & WV
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.
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