Arthrex Shoulder Suspension Tower Recalled for Loose Screw Risk
Allen Medical Systems is recalling 112 Arthrex Shoulder Suspension Towers because fastening screws may come loose and enter the sterile field.
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, but the source text explicitly states the hazard is a potential delay in surgery with no reported injuries or illnesses, fitting the criteria for a moderate risk.
Plain-English summary
Allen Medical Systems, Inc. is recalling 112 units of the Arthrex Shoulder Suspension Tower (Catalog Number AR-1650-01). The device is intended to allow for the controlled manipulation of the arm and shoulder joint during arthroscopic surgical procedures. The recall is limited to devices distributed in the state of Florida.
The recall was initiated because there is a potential scenario during use where the fastening screws attaching the covers could come loose. If this occurs, the screws could potentially land in the sterile field, which may cause a delay in surgery. The source text does not report any injuries or illnesses associated with this defect.
Healthcare facilities should identify the affected devices by checking the serial numbers listed in the official recall notice. Affected serial numbers include a range from 501798 to 501897, 510733 to 510752, and 510834 to 510840. Facilities should contact the recalling firm for instructions on how to return or replace the devices.
The recalled product
- Product
- Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral Decubitus Shoulder Positioner is intended to allow for the controlled manipulation of the arm and shoulder joint during arthroscopic surgical procedures.
- Manufacturer
- Allen Medical Systems, Inc.
- Affected units
- 112
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)
- Serial Numbers: 501798
- 501799
- 501800
- 501801
- 501802
- 501803
- 501804
- 501805
- 501806
- 501807
- 501808
- 501809
- 501810
- 501811
- 501812
- 501813
- 501814
- 501815
- 501816
- 501817
Distribution
Distributed in 1 state:
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