Recall Z-1696-2015— Zimmer, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer, Inc., initiated 2015-04-30, terminated 2016-03-15. FDA's recall record names no specific 510(k) clearance for this event. Product: PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument. Reason: Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master Bond epoxy serves as a secondary locking mechanism to fix the metal insert to the impactor head. Foreign material has been observed on the impactor block. This has the potential for a biological response..
- Recalling firm
- Zimmer, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-30
- Terminated
- 2016-03-15
- Firm location
- Warsaw, IN, United States
Product description
PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument
Reason for recall
Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master Bond epoxy serves as a secondary locking mechanism to fix the metal insert to the impactor head. Foreign material has been observed on the impactor block. This has the potential for a biological response.
Data sourced from openFDA. This site is unofficial and independent of the FDA.