Zimmer Manufacturing Recalls Self-Tapping Bone Screws Due to Fracture Risk
Zimmer Manufacturing B.V. is recalling 6,377 self-tapping bone screws used in hip surgery due to fractures caused by specific tool marks.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (fractures) in an implanted medical device, which aligns with the rubric criteria for Severe severity involving significant injury or structural defects.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 6,377 units of self-tapping bone screws used in the Trilogy Acetabular System. These devices are indicated for cemented or uncemented use in skeletally mature individuals undergoing primary or revision hip surgery. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall was initiated after analysis of returned complaint devices, product in inventory, and manufacturing records identified tool marks isolated to one specific machining mill as the cause of the fractures. The affected screws are part of the Trilogy shells, which are available in uni, multi, and cluster-holed configurations to provide additional fixation and security in cases where acetabular bone stock is deficient.
The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries including Canada, Australia, Brazil, and the United Kingdom. Specific item numbers and lot numbers are listed in the official recall notice. Patients who have had these devices implanted should contact their healthcare provider for evaluation.
The recalled product
- Product
- Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells allow for the use of screws to provide additional fixation and security, particularly in those case where acetabular bone stock…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 6,377
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Zimmer Manufacturing B.V.
See all →- HighZimmer 3.5 mm Cortical Screws Recalled for Potential Sterility Compromise
FDA (Devices) · 2016-05-25
- HighZimmer Manufacturing Recalls Sterile Hip and Trauma Implant Screws
FDA (Devices) · 2016-05-25
- HighZimmer VersaFx Femoral Fixation System Screws Recalled for Sterility Concerns
FDA (Devices) · 2016-05-25
- HighZimmer Herbert Cannulated Bone Screw Recall for Sterility Concerns
FDA (Devices) · 2016-05-25
- ModerateZimmer Recalls Sterile Hip and Trauma Implant Screws Due to Tray Defect
FDA (Devices) · 2016-05-25
Same hazard · fracture
See all →- SeverePenumbra RED 62 Reperfusion Catheter Recalled for Fracture Risk
FDA (Devices) · 2026-10-07
- HighPenumbra System RED 68 Reperfusion Catheter Recall Due to Fracture Risk
FDA (Devices) · 2026-07-29
- HighTangent Single Use Digital Catheter Recalled for Distal Shaft Fractures
FDA (Devices) · 2026-05-27
- SevereHarley-Davidson Sportster S upper triple clamp may fracture during use
NHTSA · 2026-02-09
- Severe
Similar recalls
- ModerateZimmer Manufacturing Recalls Trilogy Self-Tapping Bone Screws Due to Tray Defect
FDA (Devices) · 2016-05-25
- HighZimmer Recalls Trilogy Acetabular Shells Due to Porosity Defects
FDA (Devices) · 2013-02-13
- ModerateZimmer Recalls Trilogy Fiber Metal Acetabular Shell Due to Thread Defect
FDA (Devices) · 2014-12-31
- HighZimmer Recalls Trilogy Acetabular Shells with Porosity Defects
FDA (Devices) · 2013-02-13
- HighZimmer Recalls Trilogy Acetabular Shells Due to Porosity Defect
FDA (Devices) · 2013-02-13
- HighZimmer Recalls Trilogy Acetabular Shells for Porosity Specification Defects
FDA (Devices) · 2013-02-13