Zimmer Manufacturing Recalls 34 Sterile Bone Fixation Screws
Zimmer Manufacturing B.V. is recalling 34 sterile bone fixation screws due to insufficient sealer calibration data. The affected units were packaged between August 2010 and April 2013.
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 the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 34 units of sterile bone fixation screws, specifically item number 47486510002 (6.5 X 100 CANC SCREW, 32M), under product code HWC. These devices are metallic fasteners intended for implantation to fix bone fractures or for bone reconstructions.
The recall was initiated because of insufficient sealer calibration data for products packaged in the firm's Building II between August 2010 and April 2013. The affected products are sterile. The specific lot number for this recall is 61889945.
The affected products were distributed nationwide in the United States. Consumers and healthcare providers should check their inventory for this specific lot number and product code. If the product is found, it should be removed from use and returned to the manufacturer or a designated facility in accordance with the recall instructions.
The recalled product
- Product
- Product 13 consists of all product under product code HWC , and same usage: Item no: 47486510002 6.5 X 100 CANC SCREW, 32M Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or…
- Manufacturer
- Zimmer Manufacturing B.V.
- Hazard
- Affected units
- 34
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 no.: 61889945
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 72 recalled by Zimmer Manufacturing B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 72 products in this recall →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 · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateZimmer Recalls Bone Screws Due to Packaging Validation Deficiencies
FDA (Devices) · 2014-02-26
- ModerateZimmer EDI Periarticular Plating System Screws Recalled for Lot Commingling
FDA (Devices) · 2014-07-16
- ModerateZimmer Recalls Knee Instrument Fixation Screws Due to Packaging Failures
FDA (Devices) · 2014-09-03
- ModerateZimmer Recalls Bone Screws Due to Unvalidated Packaging Operations
FDA (Devices) · 2014-02-26
- ModerateZimmer Recalls Trauma Large Screws Due to Packaging Design Failures
FDA (Devices) · 2014-09-03
- ModerateZimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
FDA (Devices) · 2018-10-24