Zimmer Recalls Distal Lateral Femoral Locking Plates Due to Sterility Failure
Zimmer, Inc. is recalling 42,065 distal lateral femoral locking plates because testing revealed that a specific packaging tray configuration failed to maintain sterile barrier integrity.
What this means for you
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 involves a medical device with a confirmed failure of sterile barrier integrity, which poses a risk of infection (harm) to patients. The source text does not report any specific illnesses or injuries, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer, Inc. is recalling 42,065 units of the DIST LAT FEM LOCK PLT, LT (Item Numbers 47-2357-102-14 and 47-2357-102-18). The recall affects all lots with an expiration date prior to July 24, 2023. These medical devices were distributed worldwide.
The recall was initiated after a review of historic packaging validations determined that a subset of product packaged at a Zimmer facility required testing to ensure it met established requirements for sterile barrier integrity. Testing revealed that a packaging tray configuration consisting of an inner and outer sterile tray resulted in failure.
Healthcare providers and patients should stop using these specific devices. The source text does not provide specific instructions for consumers or patients regarding disposal or replacement, but the recall is driven by the risk of compromised sterility.
The recalled product
- Product
- DIST LAT FEM LOCK PLT, LT
- Manufacturer
- Zimmer, Inc.
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)
- 2023
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 8 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.
See all 8 products in this recall →Related recalls
Same manufacturer · Zimmer, Inc.
See all →- HighZimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage
FDA (Devices) · 2026-07-01
- ModerateZimmer Shoulder System Reamer Guide recalled for plastic breakage
FDA (Devices) · 2026-07-01
- ModeratePersona Revision Trabecular Metal Femoral Distal Augment recalled for packaging defect
FDA (Devices) · 2026-07-01
- HighZimmer Shoulder Reamer Guide System Recalled for Plastic Breakage
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
FDA (Devices) · 2026-07-01
Same hazard · sterility failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22