Zimmer Recalls Natural-Knee Tibial Inserts Due to Discoloration
Zimmer, Inc. is recalling 3,638 Natural-Knee Congruent Tibial Inserts with Screws because a complaint identified discoloration caused by premature oxidation during storage.
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. The hazard is a cosmetic defect (discoloration) resulting from storage conditions, with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer, Inc. is recalling 3,638 units of Natural-Knee Congruent Tibial Inserts with Screws. The affected items include specific left and right sizes (SZ1/2 and SZ3/4/5) under item numbers 620005819, 620005909, and 620006916. The devices were distributed nationwide in the United States and in several international countries, including Canada, Australia, India, and various European nations.
The recall was initiated after a complaint was received regarding a discolored All Poly Tibia. Root cause analysis determined that the discoloration resulted from free radical oxidation. This oxidation process was advanced prematurely because the machined components were stored in transparent containers exposed to artificial light for six years prior to inert packaging and sterilization.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it report any illnesses or injuries associated with the use of these implants. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Natural-Knee¿ Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 SF-CON TIB INS RT SZ1/2 9 SF-CON TIB INS RT SZ3/4/5
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 3,638
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)
- Item Number 620005819 620005909 620006916
Distribution
Part of a larger recall action
This product is one of 15 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 15 products in this recall →Related recalls
Same manufacturer · Zimmer, Inc.
See all →- HighZimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage
FDA (Devices) · 2026-07-01
- HighZimmer Shoulder Reamer Guide System 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 Off-Axis Comprehensive Shoulder System Reamer Guide Recall
FDA (Devices) · 2026-07-01
Same hazard · discoloration
See all →- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateFresenius Citrasate Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
- ModerateFresenius NaturaLyte Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
- ModerateShilpa Medicare Recalls Discolored PEMRYDI RTU Injection Vials
FDA (Drugs) · 2026-08-26
- SevereShilpa Medicare Recalls Discolored Pemetrexed Injection Vials
FDA (Drugs) · 2026-08-26
Similar recalls
- ModerateZimmer Biomet Recalls Natural-Knee II Implants Due to Packaging Residue
FDA (Devices) · 2018-03-21
- ModerateZimmer Manufacturing Recalls Sterile Knee Arthroplasty Bone Screws
FDA (Devices) · 2016-03-23
- SevereZimmer Recalls Persona Knee Implants Due to Tibial Perforation Risk
FDA (Devices) · 2012-12-26
- HighZimmer Persona Tibial Inserter Recalled for Potential Tip Fracture
FDA (Devices) · 2015-02-11
- ModerateZimmer Precoat Tibia Plates Recalled for Sealer Calibration Issues
FDA (Devices) · 2016-03-23
- ModerateZimmer Biomet Recalls Sterile Knee Implants Due to Packaging Design Failures
FDA (Devices) · 2017-06-21