Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
- Company
- Tornier, Inc
- Recall Initiated
- August 29, 2024
- Posted
- September 27, 2024
- Recall Number
- Z-3309-2024
- Quantity
- 38 units
- Firm Location
- Bloomington, MN
Reason for Recall
Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.
Distribution
US Nationwide distribution.
Lot / Code Info
GTIN 00846832084494, Batch Lot # 1495AY
Root Cause
Under Investigation by firm
Action Taken
Stryker issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 08/29/2024 via email. The notice explained the issue, potential risk, and requested the following actions be taken: Identify and isolate the affected units, and respond to the notice via email. Upon receipt of the response, Stryker will arrange for the return of the device. Those consignees who further distributed the product (to other sites or customers) were directed to notify those parties. For questions or concerns, contact: memphis.fieldaction@stryker.com.