Zimmer Recalls PRI Femoral Impactor Blocks Due to Adhesive Leak Risk
Zimmer, Inc. is recalling 1,689 PRI Femoral Impactor Blocks because uncured adhesive may leak from the device, potentially causing a biological response in patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential for biological response (injury risk) but no reported illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer, Inc. is recalling 1,689 units of the PRI Femoral Impactor Block, an orthopedic manual surgical instrument used in knee prosthesis surgery. The recall is due to a potential defect where uncured Master Bond epoxy adhesive may leak out of the assembled part following the autoclave sterilization process. This adhesive serves as a secondary locking mechanism to fix the metal threaded insert to the impactor head.
Foreign material has been observed on the impactor block, which the manufacturer states has the potential to cause a biological response in patients. The affected products were distributed worldwide, including in the United States (nationwide, including Puerto Rico and specific states) and numerous international countries such as Canada, the United Kingdom, Germany, and Japan.
Healthcare providers and facilities should stop using the affected devices immediately. Patients who have had these specific devices implanted should contact their healthcare provider for evaluation. The recall covers specific item numbers and lots as detailed in the official FDA notice.
The recalled product
- Product
- PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument
- Manufacturer
- Zimmer, Inc.
- Affected units
- 1,689
Distribution
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