Zimmer Biomet Recalls Periarticular Shoulder Plates Due to Packaging Adhesion
Zimmer Biomet is recalling 5,459,583 periarticular shoulder plates because non-highly polished implants may adhere to the LDPE bag packaging.
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 packaging defect (adhesion) for a medical device where no specific injuries or illnesses are reported in the source text, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 5,459,583 units of PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL. The affected devices are identified by specific item numbers and were manufactured prior to January 2014. These products were distributed nationwide.
The recall was initiated because non-highly polished implants may adhere to the LDPE bag, which is the previous packaging configuration for these devices. This adhesion issue is the specific defect cited in the recall notice.
The FDA has classified this recall as Class II. Consumers and healthcare providers should refer to the official FDA recall notice for specific instructions on handling the affected devices.
The recalled product
- Product
- PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 00234800106 00234800108 00234800110 00234800112 00234800114 00234800116 00234800204 00234800206 00234800208 00234800210 00234800212 00234800214 00234800216 00234800304 00234800306…
- 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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