Greatbatch Medical Recalls Linear Straight Broach Handles Due to Weld Breakage
Greatbatch Medical is recalling specific Linear Straight Broach Handles because they may break at the welds or lose the locating pin during use.
What this means for you
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 medical device with a structural defect (breaking welds/pins) that poses a risk of harm during use, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Greatbatch Medical has voluntarily initiated a recall for the Linear Straight Broach Handle (Rasp Handle) and the EZ Clean" Linear Broach Handle. The recall involves 205 units distributed to the state of Texas. The affected products include Greatbatch Part # 510397 (DJO Surgical Inc. # 803-03-159) and Greatbatch Part # T11824 (DJO Surgical Inc. # 803-03-059).
The recall was initiated after reports indicated that the products are breaking at the welds and that the locating pin at the distal end of the instrument is breaking off during use. Specific lot numbers for the Linear Straight Broach Handle are 2988946, 3138186, 3185601, 3287315, 3300879, 3333172, 3433392, and 3332697. The lot number for the EZ Clean" Linear Broach Handle is 3508491.
Healthcare providers and consumers should stop using these specific instruments immediately. Users should check their inventory for the part numbers and lot numbers listed above to determine if they possess affected units.
The recalled product
- Product
- Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Handle Greatbatch Part # T11824, DJO Surgical Inc. # 803-03-059).
- Manufacturer
- Greatbatch Medical
- Affected units
- 205
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 (8)
- Lot numbers : Linear Straight Broach Handle (Rasp Handle): 2988946
- 3138186
- 3185601
- 3287315
- 3300879
- 3333172
- 3433392
- 3332697. EZ Clean" Linear Broach Handle: 3508491.
Distribution
Distributed in 1 state:
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