Stryker Recalls Reprocessed Surgical Drill Bits Due to Packaging Seal Issues
Stryker Sustainability Solutions is recalling 1,202 reprocessed surgical drill bits and blades because packaging was not properly sealed.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because the issue is a packaging-only problem (improperly sealed packaging) with no reported injuries, illnesses, or functional defects in the surgical instruments themselves.
Plain-English summary
Stryker Sustainability Solutions is recalling 1,202 units of reprocessed surgical drill bits, blades, burs, chisels, rasps, taps, and reamers. These products are surgical accessories designed to help surgeons cut and drill bone and bony structures. The recall was initiated because it was reported that the packaging for these items was not properly sealed.
The affected products were distributed nationwide to numerous states, including Minnesota, Ohio, California, and Texas, as well as internationally to Canada. The recall covers specific item and model numbers, including 2108-109, 4125-127-090, and 2108-110, associated with lot codes such as 3743743 and 3750611.
Consumers and healthcare facilities should stop using these specific reprocessed surgical accessories and contact Stryker Sustainability Solutions for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical…
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- Affected units
- 1,202
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 (20)
- Item No/Model No: 2108-109
- 4125-127-090
- 2108-110
- 2108-115
- 2108-120
- 2108-151-001
- 2108-152
- 2108-158
- 2108-182
- 2108-218
- 310.25
- 4118-127-090
- 4125-147-090
- 4806-110-25
- 5071-553
- 6118-127-90
- 6125-127-090 Lot Code: 3743743
- 3750611
- 3750630
- 3753894
Distribution
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