Recall Z-0574-2021— Synthes (USA) Products LLC
Class II · Terminated
Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2020-11-19, terminated 2022-07-01. It names 4 FDA 510(k) clearances: K111437, K042899, K013527 and 1 more. Product: DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S. Reason: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed.
- Recalling firm
- Synthes (USA) Products LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-19
- Terminated
- 2022-07-01
- Firm location
- West Chester, PA, United States
510(k) clearances named in this recall
4 on FDA's record- K111437 — SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
- K042899 — SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS
- K013527 — MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
- K993335 — SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S
Reason for recall
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
Data sourced from openFDA. This site is unofficial and independent of the FDA.