Recall Z-2363-2015 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Stryker Howmedica Osteonics Corp.
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
| Date | Aug 10, 2015 (initiated May 12, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 21 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103835 | REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N Howmedica Osteonics Corp., May 5, 2011 |