ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Made in Cork Ireland
This recall has been terminated (originally issued August 10, 2015).
- Recall Initiated
- May 12, 2015
- Posted
- August 10, 2015
- Terminated
- October 5, 2016
- Recall Number
- Z-2363-2015
- Quantity
- 21 units
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part # 5901-E-4818 Lot MAC7C14, offset humeral head trial.
Distribution
US Nationwide
Lot / Code Info
Catalog #5901-S-4818, Lot MAC7C14.
Root Cause
Process control
Action Taken
Stryker Orthopaedics notified their branches/agencies via email on 5/12/2015 and sent notification letters and product accountability forms to hospital risk management/branches on 7/15/2015 and 7/16/2015
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