Synthes (USA) Products LLC recalls SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical pro…
- Recall date
- December 1, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0585-2016
- FDA classification
- Class II
- Brand / firm
- Synthes (USA) Products LLC
- Sold / distributed
- US nationwide distibution.
Why it was recalled
The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
Get recall alerts
Free email alert whenever Synthes (USA) Products LLC has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Synthes (USA) Products LLC