Bead TIP GD Wire 3.0mm X 60cm recall: Sterility Concern
BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails).…
Why was Bead TIP GD Wire 3.0mm X 60cm recalled?
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
563080 563090 407870 408160 408140 412690 412750 412720 412740 668840 202750 389030 410170 410180 395170 513920 201790 232930 639560 800410 980930 134560 271820 351760 504870 578400 605700 750960 750970 913730 921150 058010 631570 969080 101380 944200 969090 203000 449730 449740 449750 449720 665510 820130 850170 978340 221240 419010 848820 848810 278720 387620 437340 502200 623450 038560 186020 212630 183170 183180 183190 434630 183200 930950 693480
- Product
- BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails).…
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 2168
- Distribution
- Worldwide Distribution: US (Nationwide) and countries of: Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and Netherlands.
- Recall date
- June 27, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)