Recall record at a glance
| Official record | Z-1198-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Allen Medical Systems, Inc. |
| Report date | Feb 22, 2017 |
| Recall initiation date | Jan 3, 2017 |
| Quantity | 112 devices |
| Location | Acton, MA, United States |
Official product description
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.
Why the product was recalled
During use, there is a potential scenario which could allow the fastening screws attaching covers to come loose and potentially land in the sterile field causing a delay in surgery.
Distribution information
US state of FL
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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