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.
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 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…
- 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
- HighOrthopedic Implant Recall: Excessive Radiation Exposure in Revision Tibial Insert
FDA (Devices) · 2023-03-29
- HighDePuy Attune Tibial Insert Recalled for Excessive Radiation Exposure
FDA (Devices) · 2023-03-29
- HighAttune Revision Tibial Insert Recalled for Excessive Gamma Radiation Exposure
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 →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateSynthes Recalls 3.7mm Cannulated Screws Due to Incorrect Labeling
FDA (Devices) · 2015-06-24
- HighEncore Medical Recalls 6.5mm Cancellous Bone Screws Due to Labeling Errors
FDA (Devices) · 2012-10-31
- ModerateEncore Medical Recalls Mislabelled 6.5 mm Cancellous Bone Screws
FDA (Devices) · 2012-08-15
- ModerateStryker Recalls Cancellous Bone Screws Due to Packaging Error
FDA (Devices) · 2013-12-18
- HighDePuy Pinnacle Hip Cups Recalled for Potential Cross-Threaded Apex HE Fixation
FDA (Devices) · 2021-01-13
- ModerateDePuy Recalls AltrX Hip Liners Due to Incorrect Box Labeling
FDA (Devices) · 2013-05-29