Zimmer EDI Periarticular Plating System Screws Recalled for Lot Commingling
Zimmer Manufacturing B.V. is recalling 496 bone screws because two lots were commingled and packaged with incorrect labels.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the issue is a labeling and packaging error (commingling) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 496 units of Zimmer EDI Periarticular Plating System screws, specifically the 4mm diameter, 14mm length and 4.0mm diameter, 20mm length models. These temporary internal fixation devices are designed to stabilize fractures during the normal healing process.
The recall was initiated because two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759, and screws for lot number 62628759 were packaged in bags labeled for lot number 62629432. The affected product was distributed between March 6, 2014, and April 21, 2014.
The affected product was distributed worldwide, including the United States (nationwide), India, Japan, China, Australia, and Canada. Healthcare providers and patients should contact Zimmer Manufacturing B.V. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary internal fixation devices, designed to stabilize fractures during the normal healing…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 496
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot No. 62629432 Lot No. 62628759
Distribution
Distributed nationwide across the United States.
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