Zimmer Biomet Recalls Peri Dist Volar/Dorsal T/Dorsal Delta Radial Implants
Zimmer Biomet is recalling specific wrist implants because non-highly polished devices may adhere to the packaging bag.
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 hazard involves a packaging issue (adherence to the bag) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling specific PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL implants. The recall involves 5,459,583 total devices that were distributed nationwide. The affected products include various item numbers and were all manufactured prior to January 2014.
The recall is being conducted because non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration. This issue could potentially affect the handling or integrity of the device during the packaging process.
Healthcare providers and patients who have received these specific implants should contact their healthcare provider or Zimmer Biomet for further information and instructions on how to proceed.
The recalled product
- Product
- PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL, Item Nos. 00234801303 00234801304 00234801306 00234801308 00234801310 00234801312 00234801403 00234801404 00234801406 00234801408 00234801410 00234801412 00234802102 00234802104 00234802106 00234802108 00234802110…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 5,459,583
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)
- All product manufactured prior to January 2014.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 41 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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