DePuy Recalls Pinnacle Cancellous Screws Due to Labeling Error
DePuy Orthopaedics is recalling 118 Pinnacle Cancellous Screws because the labels incorrectly identify them as Cannulated Screws.
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 involves a minor labeling error (incorrect product name) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
DePuy Orthopaedics, Inc. is issuing a voluntary recall of ten lots of the Pinnacle Cancellous Screw. The recall is due to an incorrect description on the product label. The label currently reads "Pinnacle Cannulated Screw" but should correctly read "Pinnacle Cancellous Screw."
The affected products are ancillary fixation devices used in total hip arthroplasties to secure Pinnacle Acetabular Shell implants. The recall involves 118 units distributed nationwide to the states of Georgia, Massachusetts, Minnesota, South Carolina, and Virginia. The specific catalog number is 121708500, and the affected lot numbers are 227619, 227620, 227621, 227622, 227627, 227630, 227646, 227650, 227651, and 227656.
Consumers and healthcare providers should check their inventory for these specific lot numbers and catalog number. If the product is found, it should be returned to DePuy Orthopaedics, Inc. for credit or replacement.
The recalled product
- Product
- Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside an uncoated Tyvek/PET peel pouch and sealed. This package is placed into a paperboard carton, labeled and shrink-wrapped. PINNACLE¿ CANCELLOUS Bone Screws are ancil
- Manufacturer
- DePuy Orthopaedics, Inc.
- Hazard
- Affected units
- 118
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 (10)
- Catalog number: 121708500 and Lot numbers: 227619
- 227620
- 227621
- 227622
- 227627
- 227630
- 227646
- 227650
- 227651
- and 227656.
Distribution
Related recalls
Same manufacturer · DePuy Orthopaedics, Inc.
See all →- HighATTUNE AFFIXIUM Knee Implant Component Recalled for Incorrect Labeling
FDA (Devices) · 2024-04-10
- HighAttune Revision Limb Preservation System Tibial Insert Recalled for Over-Irradiation
FDA (Devices) · 2023-03-29
- HighDePuy Attune Tibial Insert Recalled for Excessive Radiation Exposure
FDA (Devices) · 2023-03-29
- HighOrthopedic Implant Recall: Excessive Radiation Exposure in Revision Tibial Insert
FDA (Devices) · 2023-03-29
- HighOrthopedic Tibial Insert Recalled Due to Excessive Radiation Exposure
FDA (Devices) · 2023-03-29
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02