Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling 56 sterile bone fixation screws 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 involves a risk-of-harm product (sterile implant) where the integrity of the sterile barrier is compromised due to calibration issues, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 56 sterile bone fixation screws, including various sizes of periosteal screws, due to insufficient sealer calibration data. The affected products were packaged in the firm's Building II between August 2010 and April 2013. The recall covers specific item numbers and lot numbers listed in the official notice.
The hazard is related to the integrity of the sterile packaging. Because the sealer calibration data was insufficient, there is a potential risk that the sterile barrier may not be fully effective, which could compromise the sterility of the implants. The products are currently classified as sterile.
Healthcare providers and patients who have received these specific implants should contact their healthcare provider for evaluation. Consumers should not use the affected products if they have not yet been implanted. The recall is distributed nationwide in the United States.
The recalled product
- Product
- Product 56 consists of all product under product code: HWC and same usage: Item no: 47234702032 PERI SCR 3.5MM X 32MM STE 47234702018 PERI SCR. 3.5MM X 18MM ST 47234702020 PERI SCR. 3.5MM X 20MM ST 47234702022 PERI SCR. 3.5MM X 22MM ST 47234702026 PERI SCR. 3.5MM X 26MM…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 56
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.
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