Zimmer Manufacturing Recalls Sterile Intramedullary Nails Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 1,102 sterile intramedullary nails distributed nationwide. The recall is due to insufficient sealer calibration data for products 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, risk-of-harm products where injury has not yet been reported are assigned a score of 3 (High).
Plain-English summary
Zimmer Manufacturing B.V. is recalling 1,102 units of sterile intramedullary nails, including various diameters of M/DN R-F IM Nails and M/DN Tibial I/M Nails. The affected products were packaged in the firm's Building II between August 2010 and April 2013.
The recall was initiated because of insufficient sealer calibration data for the affected sterile products. The source text does not specify reported illnesses, injuries, or deaths associated with this recall.
The affected products were distributed nationwide in the United States. Consumers and healthcare providers should check their inventory for the specific item numbers and lot numbers listed in the official recall notice and stop using the affected products.
The recalled product
- Product
- Product 43 consists of all product under product code: HSB and same usage: Item no: 224001016 M/DN R-F IM NAIL 10MM DIA 224001018 M/DN R-F IM NAIL 10MM DIA 224001020 M/DN R-F IM NAIL 10MM DIA 224001022 M/DN R-F IM NAIL 10MM DIA 224001024 M/DN R-F IM NAIL 10MM DIA…
- Manufacturer
- Zimmer Manufacturing B.V.
- Hazard
- Affected units
- 1,102
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 Humeral Intramedullary Nails Due to Packaging Validation Issues
FDA (Devices) · 2014-02-26
- ModerateZimmer Biomet Recalls Sterile Tibial Intramedullary Nails Due to Packaging Failures
FDA (Devices) · 2017-06-21
- ModerateZimmer Recalls M/DN R-F IM Nails Due to Packaging Validation Issues
FDA (Devices) · 2014-02-26
- ModerateZimmer Biomet Recalls Tibial Intramedullary Nails Due to Packaging Failures
FDA (Devices) · 2017-06-21
- ModerateZimmer Biomet Recalls Sterile Femoral Intramedullary Nails Due to Packaging Failures
FDA (Devices) · 2017-06-21
- ModerateZimmer Biomet Recalls Sterile Intramedullary Nail Implants Due to Packaging Failures
FDA (Devices) · 2017-06-21