AC joint fixation implants recalled over potentially missing slotted button assembly
Biomet is recalling 98 ZipTight Acute AC Joint Implants from one lot because of the potential for a missing slotted button assembly.
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: Scored 3 under the risk-of-harm criterion: a missing component in an implant kit could disrupt a surgical repair, and no injuries are reported.
Plain-English summary
The BIOMET ZipTight Acute AC Joint Implant, Single Ziploop, model/catalog number 904834, a fixation system for AC joint repair, is being recalled.
There is a potential for a missing slotted button assembly in one lot of the implant.
The recall covers 98 units carrying UDI-DI (01)00880304478404, lot number 0002587666. The enforcement record refers to an attached consignee list and distribution history for the affected sites. The FDA has classified the action as Class II.
The enforcement record describes the missing component and reports no injuries. Facilities should verify the contents of affected lot stock before use and follow Biomet's instructions.
The recalled product
- Product
- BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
- Manufacturer
- Biomet, Inc.
- Affected units
- 98
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)
- UDI-DI (01)00880304478404(17)290130(10)0002587666
- Lot Number 0002587666
Distribution
Distribution scope not specified by the agency.
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