Zimmer Recalls Knee Instrument Fixation Screws Due to Packaging Failures
Zimmer, Inc. is recalling 972,125 units of knee fixation screws worldwide because packaging design verification tests failed, potentially compromising sterility.
What this means for you
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, but the source text describes a packaging verification failure without reporting any specific illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving potential risk without confirmed harm.
Plain-English summary
Zimmer, Inc. is recalling 972,125 units of sterile-packaged knee instrument fixation screws. The affected products include 48mm headed and headless screws, as well as MIS (Minimally Invasive Surgery) headed and headless screws in 48mm lengths. The recall covers items with expiration dates prior to November 2023 and specific item numbers 00579104100, 00579104200, 00598304048, and 00598304148.
The recall was initiated due to packaging design verification test failures. Multiple test samples from six different package configurations failed simulated distribution and shipping testing. During these tests, devices either breached the inner or outer package trays, or the seal integrity was lost. This suggests that the packaging may not reliably maintain the sterile environment required for these implants and instruments during distribution.
The affected products were distributed worldwide. Healthcare providers and facilities that have received these specific items should stop using them and contact Zimmer, Inc. for further instructions on return or disposal. Patients who have already received these implants should consult their healthcare provider if they have concerns regarding the packaging integrity or potential sterility issues.
The recalled product
- Product
- Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM
- Manufacturer
- Zimmer, Inc.
- Affected units
- 972,125
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 (4)
- Item Numbers 00579104100
- 00579104200
- 00598304048
- 00598304148 Exp Date Prior to 2023-11
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by Zimmer, 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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