Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp.
FDA Recall Z-0060-2017 · Posted 2016-10-07
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeHWA
Date Initiated2016-08-18
Date Terminated2018-08-01
Product Quantity3,768 units
Reason for Recall
Stryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the Trident Universal Impactor/Positioner.
Firm Action
Stryker sent an Urgent Medical Device Recall Notification dated August 18, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Actions Needed:
1. Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization.
2. Branches/Agencies: Return all affected products available at your location to
Stryker C/0 Stericycle
3. Hospitals/Branches: Complete and sign the enclosed Business Reply Form and fax a copy to 877-546-0444 or email to Stericycle [email protected].
Our records indicate that you have received the above referenced instrument. It is our responsibility to ensure that customers who may have received this affected instrument also receive this important communication. Please assist us in meeting our regulatory obligation by faxing back the attached Business Reply Form within 5 days.
We regret any inconvenience this action may cause you and if you have any questions, feel free to contact me at (201) 831-6693.
For further questions regarding this recall, please call (201) 831-5000.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US and Internationally
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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