Ankle Arthrodesis Nail, right T2 Ankle 11x300mm, Product… recallZ-2408-2018 · Stryker GmbH · initiated Apr 27, 2018

Why it was recalled

The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.

FDA root cause category: Employee error

What the company is doing

Urgent Product Recall letters dated 4/27/18 were distributed to customers. The letters instructed customers to perform the following actions: 1. Inform individuals within your organization who need to be aware of this device recall. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. Response is required, even though you may not have any physical inventory on site anymore. 3. Quarantine and discontinue use of the recalled devices. 4. Maintain awareness of this notice internally until all required actions have been completed within your facility 5. Inform Stryker if any of the subject devices have been distributed to other organizations. a) Please provide contact details so that Stryker can inform the recipients appropriately. b) If you are a Distributor, note that you are responsible for notifying your affected customers. 6. Branches/Agencies: Return all affected products available at your location to: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 PR 1774317 Event 6020 7. Hospitals/Branches/Agencies: Complete and sign the enclosed Business Reply Form and fax to 1-888-230-2125 or to Email: [email protected]

Recall details

Recall number

Z-2408-2018

Status

Terminated

Initiated by the company

Apr 27, 2018

Recalling firm

Stryker GmbH

Product code

HSB

FDA submissions

K003018

Distribution

The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.

Product description

Ankle Arthrodesis Nail, right T2 Ankle 11x300mm, Product Number 18191130S

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• T2 1819-1130S

  Stryker GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 80131).

• Z-2393-2018 · Terminated
  Tibial Nail, Standard T2 Tibia 12x315 mm, Product Number 18221231S
• Z-2394-2018 · Terminated
  Femoral Nail, A/R T2 Femur 10x320 mm, Product Number 18251032S
• Z-2395-2018 · Terminated
  Femoral Nail, A/R T2 Femur 10x340 mm, Product Number 18251034S
• Z-2396-2018 · Terminated
  Femoral Nail, A/R T2 Femur 12x360 mm, Product Number 18251236S
• Z-2397-2018 · Terminated
  Femoral Nail, A/R T2 Femur 15x240 mm, Product Number 18251524S
• Z-2398-2018 · Terminated
  Femoral Nail, A/R, R1500 T2 Femur 10x320 mm, Product Number 18281032S
• Z-2399-2018 · Terminated
  Femoral Nail, A/R, R1500 T2 Femur 12x300 mm, Product Number 18281230S
• Z-2400-2018 · Terminated
  Femoral Nail, A/R, R1500 T2 Femur 12x360 mm, Product Number 18281236S
• Z-2401-2018 · Terminated
  Femoral Nail, A/R, R1500 T2 Femur 12x380 mm, Product Number 18281238S
• Z-2402-2018 · Terminated
  Femoral Nail, LEFT T2 GTN 10x360 mm, Product Number 18501036S
• Z-2403-2018 · Terminated
  Femoral Nail, LEFT T2 GTN 12x360 mm, Product Number 18501236S
• Z-2404-2018 · Terminated
  Femoral Nail, LEFT T2 GTN 14x300 mm, Product Number 18501430S
• Z-2405-2018 · Terminated
  Femoral Nail, RIGHT T2 GTN 9x320 mm, Product Number 18510932S
• Z-2406-2018 · Terminated
  Femoral Nail, RIGHT T2 GTN 14x460 mm, Product Number 18511446S
• Z-2407-2018 · Terminated
  Ankle Arthrodesis Nail, right T2 Ankle 10x300mm, Product Number 18191030S