Femoral Nail, A/R, R1500 T2 Femur 10x320 mm, Product Number 18281032S
Recall
- Recall Number
- Z-2398-2018
- Event Number
- 80131
- Firm
- Stryker GmbH Bohnackerweg 1 Selzach Switzerland
- FEI Number
- 3002807830
- Product Code
- HSB
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- April 27, 2018
- Terminated
- May 21, 2020
Description
Femoral Nail, A/R, R1500 T2 Femur 10x320 mm, Product Number 18281032S
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Urgent Product Recall letters dated 4/27/18 were distributed to customers. The letters instructed customers to perform the following actions: 1. Inform individuals within your organization who need to be aware of this device recall. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. Response is required, even though you may not have any physical inventory on site anymore. 3. Quarantine and discontinue use of the recalled devices. 4. Maintain awareness of this notice internally until all required actions have been completed within your facility 5. Inform Stryker if any of the subject devices have been distributed to other organizations. a) Please provide contact details so that Stryker can inform the recipients appropriately. b) If you are a Distributor, note that you are responsible for notifying your affected customers. 6. Branches/Agencies: Return all affected products available at your location to: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 PR 1774317 Event 6020 7. Hospitals/Branches/Agencies: Complete and sign the enclosed Business Reply Form and fax to 1-888-230-2125 or to Email: [email protected]
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
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