ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgic
FDA device recall Z-2363-2015 · posted 2015-08-10 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- 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.
- 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
- Root cause
- Process control
- Status
- Terminated
- Product code
- KWS
- Quantity affected
- 21 units
- Distribution
- US Nationwide
- Date initiated
- 2015-05-12
- Date posted
- 2015-08-10
- Date terminated
- 2016-10-05
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N (K103835) | Howmedica Osteonics Corp. | 2011-05-05 |