Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking P
FDA device recall Z-1314-2015 · posted 2015-03-24 · Terminated
Recall details
- Recalling firm
- Flower Orthopedics Corporation
- Reason for recall
- Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg.
- Action taken
- On February 16, 2015, Flower Orthopedics generated and distributed a field memo/advisory notice (FOCMB-15-02) to all distributors with locking peg inventory on February 6, 2015. The field memo provided technique guidance to end users. All 12 consignees with remaining inventory (ie.not reported as used) were contacted directly via phone and all have agreed to ship the locking pegs back to Flower Orthopedics. Flower Orthopedics determined that a generic statement to all customers was not necessary for the following reasons detailed above and summarized again here: product was distributed only through direct channels, the health hazard evaluation has determined there is a very low risk to health, and all consignees have been directly contacted already and product inventory is being returned.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 901
- Distribution
- Distributed in the states of VA, TX, IL, OK, PA, CA, NY, KY, and FL.
- Date initiated
- 2015-02-16
- Date posted
- 2015-03-24
- Date terminated
- 2015-08-06
- Location
- Horsham, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLOWER SMALL AND MEDIUM IMPLANT SET (K131657) | Flower Orthopedics Corporation | 2013-08-22 |
| FLOWER SMALL AND MEDIUM BONE IMPLANTS (K123562) | Flower Orthopedics Corporation | 2013-03-29 |