Zimmer Recalls 28 Distal Radial Volar Plates Due to Screw Locking Failure
Zimmer, Inc. is recalling 28 units of the Distal Radial Volar Plate Lateral Column because a defect prevented screws from locking, causing them to pull through the plate.
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 is classified as FDA Class II. The hazard involves a structural failure of a medical implant (screw pull-through) which poses a risk of harm, but the source text does not report any injuries, hospitalizations, or fatalities, placing it in the 'High' severity category per the rubric.
Plain-English summary
Zimmer, Inc. is recalling 28 units of the Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). These orthopedic fixation plates are used for temporary internal fixation and stabilization of osteotomies and fractures.
The recall was initiated after a complaint reported that an 8-hole plate from lot 62276042 had an enlarged hole that was unable to lock the screw. This defect resulted in the screw head pulling through the plate hole.
The affected product is identified by Part Number 00-2358-014-04 and Lot 62276042. The units were distributed worldwide, including in the United States (specifically California and Ohio) and in Brazil, China, Korea, and Taiwan. Healthcare providers and patients should contact Zimmer, Inc. for further instructions regarding the removal or replacement of the affected devices.
The recalled product
- Product
- Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilization of osteotomies and fractures.
- Manufacturer
- Zimmer, Inc.
- Affected units
- 28
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 (2)
- Part Number 00-2358-014-04
- lot 62276042
Distribution
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