| Date Initiated by Firm | August 08, 2023 |
|---|
| Date Posted | January 29, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0843-2024 |
|---|
| Recall Event ID |
93729 |
| 510(K)Number | K191146 |
|---|
| Product Classification |
shoulder prosthesis, reverse configuration - Product Code PHX
|
| Product | Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210 |
|---|
| Code Information |
UDI-DI: 03701037309551, Lot: U0191 |
| FEI Number |
3014128390
|
Recalling Firm/
Manufacturer |
FX SHOULDER
13465 Midway Rd Ste 310
Dallas TX 75244-5183
|
| For Additional Information Contact | Matt Glaser
800-429-8965 |
|---|
Manufacturer Reason
for Recall | Centered glenosphere box may contain an eccentric glenosphere. |
|---|
FDA Determined
Cause 2 | Labeling mix-ups |
|---|
| Action | On 8/8/23, the firm telephoned the customer and informed them of the recall. The customer was asked to quarantine the device, which was subsequently collected by the firm. |
|---|
| Quantity in Commerce | 4 |
|---|
| Distribution | US Nationwide distribution in the state of NJ. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = PHX
|
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