Device recall: Tibial Nail, Standard T2 Tibia 12x315 mm, Product Number 18221231S
Class II FDA enforcement event 80131. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Stryker GmbH started this device recall on 27 Apr 2018. The firm address in the FDA record is in Selzach. FDA put the recall in Class II. FDA event 80131 has 16 product records. The first FDA enforcement report date is 18 Jul 2018. The record gives the status Terminated, with the termination date 21 May 2020.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
Recalling firm
Stryker GmbH, Selzach, Switzerland.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
16 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2393-2018 | Tibial Nail, Standard T2 Tibia 12x315 mm, Product Number 18221231S | 12 | Class II | Terminated | 18 Jul 2018 |
| Z-2394-2018 | Femoral Nail, A/R T2 Femur 10x320 mm, Product Number 18251032S | 2 | Class II | Terminated | 18 Jul 2018 |
| Z-2395-2018 | Femoral Nail, A/R T2 Femur 10x340 mm, Product Number 18251034S | 17 | Class II | Terminated | 18 Jul 2018 |
| Z-2396-2018 | Femoral Nail, A/R T2 Femur 12x360 mm, Product Number 18251236S | 9 | Class II | Terminated | 18 Jul 2018 |
| Z-2397-2018 | Femoral Nail, A/R T2 Femur 15x240 mm, Product Number 18251524S | 1 | Class II | Terminated | 18 Jul 2018 |
| Z-2398-2018 | Femoral Nail, A/R, R1500 T2 Femur 10x320 mm, Product Number 18281032S | 7 | Class II | Terminated | 18 Jul 2018 |
| Z-2399-2018 | Femoral Nail, A/R, R1500 T2 Femur 12x300 mm, Product Number 18281230S | Class II | Terminated | 18 Jul 2018 | |
| Z-2400-2018 | Femoral Nail, A/R, R1500 T2 Femur 12x360 mm, Product Number 18281236S | Class II | Terminated | 18 Jul 2018 | |
| Z-2401-2018 | Femoral Nail, A/R, R1500 T2 Femur 12x380 mm, Product Number 18281238S | Class II | Terminated | 18 Jul 2018 | |
| Z-2402-2018 | Femoral Nail, LEFT T2 GTN 10x360 mm, Product Number 18501036S | Class II | Terminated | 18 Jul 2018 | |
| Z-2403-2018 | Femoral Nail, LEFT T2 GTN 12x360 mm, Product Number 18501236S | Class II | Terminated | 18 Jul 2018 | |
| Z-2404-2018 | Femoral Nail, LEFT T2 GTN 14x300 mm, Product Number 18501430S | Class II | Terminated | 18 Jul 2018 | |
| Z-2405-2018 | Femoral Nail, RIGHT T2 GTN 9x320 mm, Product Number 18510932S | Class II | Terminated | 18 Jul 2018 | |
| Z-2406-2018 | Femoral Nail, RIGHT T2 GTN 14x460 mm, Product Number 18511446S | Class II | Terminated | 18 Jul 2018 | |
| Z-2407-2018 | Ankle Arthrodesis Nail, right T2 Ankle 10x300mm, Product Number 18191030S | Class II | Terminated | 18 Jul 2018 | |
| Z-2408-2018 | Ankle Arthrodesis Nail, right T2 Ankle 11x300mm, Product Number 18191130S | Class II | Terminated | 18 Jul 2018 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2018
- 1,074
- Share of these events in Class II
- 92%
- Product records in this event
- 16Median of the firm: 1
- Events of the firm on the register
- 21
Other events of the firm
Official channels
- FDA enforcement report Z-2393-2018The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 80131. https://recallregister.com/fda/ii/80131/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
- What quantity of product is in FDA event 80131?
- The event has 16 product records. The first record gives this quantity:
12
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 92% of the 1,074 device events that started in 2018 are in Class II.