Recall Z-2093-2013— Zimmer, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer, Inc., initiated 2013-06-19, terminated 2015-06-16. It names one FDA 510(k) clearance: K830196. Product: VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profiles, several holes/length combinations (2/54, 3/70, 4/86, 5/102, 6/118) and several angles (130, 135, 140, 145 and 150). Item codes starting with 00-1193-130, 00-1193-135, 00-1193-140, 00-1193-145, 00-1193-150. orthopedic implant.. Reason: Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product..
- Recalling firm
- Zimmer, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-06-19
- Terminated
- 2015-06-16
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profiles, several holes/length combinations (2/54, 3/70, 4/86, 5/102, 6/118) and several angles (130, 135, 140, 145 and 150). Item codes starting with 00-1193-130, 00-1193-135, 00-1193-140, 00-1193-145, 00-1193-150. orthopedic implant.
Reason for recall
Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.