Synthes Periprosthetic Locking Screw Recalled for Post-Expiration Shipment
Synthes (USA) Products LLC is recalling 15 units of 5.0 mm Periprosthetic Locking Screws shipped after their expiration date.
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: This is a voluntary precautionary recall for a documentation/shipping error (post-expiration shipment) with no reported illnesses or injuries, fitting the Moderate severity criteria.
Plain-English summary
Synthes (USA) Products LLC is recalling 15 units of 5.0 mm Periprosthetic Locking Screws, Self-tapping, 12 mm Sterile (Catalog ID # 02.221.462S). The specific lot number is 5539094, with a manufacture date of 07/02/2007 and an expiration date of 05/31/2012.
The recall was initiated because the lot was shipped after the expiration date of May 31, 2012. The source text notes that the label on the product displays the correct expiration date. The product is indicated for the fixation of various long bones.
The affected units were distributed in Illinois (IL) and Indiana (IN). No illnesses or injuries are reported in the source text. Healthcare providers and patients should stop using the affected units and contact Synthes (USA) Products LLC for further instructions.
The recalled product
- Product
- 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones.
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 15
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)
- Lot Number 5539094
Distribution
Related recalls
Same manufacturer · Synthes (USA) Products LLC
See all →- HighVOLT locking screw taps swapped between lots carry incorrect thread
FDA (Devices) · 2026-04-08
- HighVOLT bone taps swapped between lots carry the incorrect thread
FDA (Devices) · 2026-04-08
- ModerateLocking bone screws recalled after packaging labeled with the wrong length
FDA (Devices) · 2025-10-29
- ModerateForty six millimetre locking screws recalled over wrong length on packaging
FDA (Devices) · 2025-10-29
- HighSurgical screwdrivers recalled for failure to engage with implant screws
FDA (Devices) · 2024-06-05
Same hazard · expired product
See all →- ModerateExpressaire Disposable Tourniquet Cuff Recalled for Incorrect Expiration Date
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateFDA Recalls Expressaire Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateFDA Recalls Expressaire Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
Similar recalls
- HighSynthes Recalls 3.7mm and 5.0mm Dynamic Locking Screws Due to Breakage
FDA (Devices) · 2013-12-04
- ModerateSynthes Recalls 4.5mm Multiloc Screws Due to Incorrect Size Labeling
FDA (Devices) · 2012-08-01
- HighSynthes Dynamic Locking Screw System Recalled for Pin Breakage
FDA (Devices) · 2015-09-30
- ModerateSynthes Recalls 4.5 mm Cannulated Screws Due to Labeling Errors
FDA (Devices) · 2016-07-20
- ModerateSynthes 6.5 mm Cannulated Screw Recalled for Labeling Mismatch
FDA (Devices) · 2016-07-20
- ModerateSynthes 2.4 and 2.7 mm Locking Screws Recalled for Mislabeling
FDA (Devices) · 2013-12-04