Zimmer Biomet Recalls Partial Knee Spacer Block Instruments
Zimmer Biomet is recalling specific Persona Partial Knee spacer block instruments because they do not fit in the alignment tower instrument or handle.
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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 1,023 units of Persona Partial Knee spacer block instruments. The affected products include 8mm, 9mm, 10mm, 12mm, and 14mm blocks with specific model numbers and lot numbers. These instruments are used during surgery to ensure tibial resection is sufficient and to verify limb alignment.
The recall was initiated because certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle. This defect could affect the precision of the surgical procedure.
The products were distributed nationwide in the United States to 33 states, as well as internationally to Japan and the Netherlands. Healthcare providers and facilities should stop using the affected instruments and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm block, Model Number: 42-5399-035-10; (4) 12mm block, Model Number: 42-5399-035-12; (5) 14mm block, Model Number: 42-5399-035-14 A spac
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 1,023
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 (15)
- (1) 8mm block
- Model Number: 42-5399-035-08
- Lots: 63767442 and 63807190
- (2) 9mm block
- Model Number:42-5399-035-09
- Lot: 63769804
- (3) 10mm block
- Model Number: 42-5399-035-10
- Lot: 63769805
- (4) 12mm block
- Model Number: 42-5399-035-12
- Lot: 63769806
- (5) 14mm block
- Model Number: 42-5399-035-14
- Lots: 63767443 and 63813674
Distribution
Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · fitting defect
See all →- ModerateMedline Procedure Kits Recalled Due to Dimensional Fitting Issues
FDA (Devices) · 2024-08-28
- ModerateMedline Medical Procedure Kits Recalled for Dimensional Variation Affecting Outer Canister Fit
FDA (Devices) · 2024-08-28
- HighMedline ENDO KIT procedure kits recalled for dimensional variation affecting fit
FDA (Devices) · 2024-08-28
- ModerateMedline Medical Soft Liner Recall Due to Dimensional Variation
FDA (Devices) · 2024-08-28
- HighMedtronic Percutaneous Pins Recalled for Potential Fitting and Removal Issues
FDA (Devices) · 2024-01-17